Other Medical Devices Recalls

Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588

Konica Minolta Medical Imaging USA

Class I - Dangerous

There is a risk of circuit board breakage within the main housing of the AC Adapter unit. Smoke may be emitted from the AC Adapter as a direct result.

Dec 4, 2017 Other Medical Devices Nationwide View Details →

ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR

Johnson & Johnson Vision Care

Class I - Dangerous

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Oct 19, 2017 Other Medical Devices Nationwide View Details →

Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Nov 9, 2017 Other Medical Devices View Details →

(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706

DePuy Orthopaedics

Class I - Dangerous

The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.

Dec 21, 2017 Other Medical Devices Nationwide View Details →

ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER TROC NAIL 130 DEG X 11MM STER TROC NAIL 135 DEG X 11MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Nov 9, 2017 Other Medical Devices View Details →

ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS

Johnson & Johnson Vision Care

Class I - Dangerous

Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Oct 19, 2017 Other Medical Devices Nationwide View Details →

PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Nov 9, 2017 Other Medical Devices View Details →

11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Nov 9, 2017 Other Medical Devices View Details →

ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600

Deerfield Imaging

Class I - Dangerous

The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.

Feb 23, 2018 Other Medical Devices View Details →

ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STER L H TROC NAIL 360X9X125 STER L H TROC NAIL 380X9X125 STER L H TROC NAIL 400X9X125 STER L H TROC NAIL 420X9X125 STER L H TROC NAIL 440X9X125 STER L H TROC NAIL 460X9X125 STER L H TROC NAIL 320X11X125 STER L H TROC NAIL 340X11X125 STER L H TROC NAIL 360X11X125 STER L H TROC NAIL 380X11X125 STER L H TROC NAIL 400X11X125 STER L H TROC NAIL 420X11X125 STER L H TROC NAIL 440X11X125 STER L H TROC NAIL 460X11X125 STER L H TROC NAIL 320X13X125 STER L H TROC NAIL 340X13X125 STER L H TROC NAIL 360X13X125 STER L H TROC NAIL 380X13X125 STER L H TROC NAIL 400X13X125 STER L H TROC NAIL 420X13X125 STER L H TROC NAIL 440X13X125 STER L H TROC NAIL 460X13X125 STER R H TROC NAIL 320X9X125 STER R H TROC NAIL 340X9X125 STER R H TROC NAIL 360X9X125 STER R H TROC NAIL 380X9X125 STER R H TROC NAIL 400X9X125 STER R H TROC NAIL 420X9X125 STER R H TROC NAIL 440X9X125 STER R H TROC NAIL 460X9X125 STER R H TROC NAIL 320X11X125 STER R H TROC NAIL 340X11X125 STER R H TROC NAIL 360X11X125 STER R H TROC NAIL 380X11X125 STER R H TROC NAIL 400X11X125 STER R H TROC NAIL 420X11X125 STER R H TROC NAIL 440X11X125 STER R H TROC NAIL 460X11X125 STER R H TROC NAIL 320X13X125 STER R H TROC NAIL 340X13X125 STER R H TROC NAIL 360X13X125 STER R H TROC NAIL 380X13X125 STER R H TROC NAIL 400X13X125 STER R H TROC NAIL 420X13X125 STER R H TROC NAIL 440X13X125 STER R H TROC NAIL 460X13X125 STER L H TROC NAIL 320X11X130 STER L H TROC NAIL 320X9X130 STER L H TROC NAIL 340X9X130 STER L H TROC NAIL 360X9X130 STER L H TROC NAIL 380X9X130 STER L H TROC NAIL 400X9X130 STER L H TROC NAIL 420X9X130 STER L H TROC NAIL 440X9X130 STER L H TROC NAIL 460X9X130 STER L H TROC NAIL 340X11X130 STER L H TROC NAIL 360X11X130 STER L H TROC NAIL 380X11X130 STER L H TROC NAIL 400X11X130 STER L H TROC NAIL 420X11X130 STER L H TROC NAIL 440X11X130 STER L H TROC NAIL 460X11X130 STER L H TROC NAIL 320X13X130 STER L H TROC NAIL 340X13X130 STER L H TROC NAIL 360X13X130 STER L H TROC NAIL 380X13X130 STER L H TROC NAIL 400X13X130 STER L H TROC NAIL 420X13X130 STER L H TROC NAIL 440X13X130 STER L H TROC NAIL 460X13X130 STER R H TROC NAIL 320X9X130 STER R H TROC NAIL 340X9X130 STER R H TROC NAIL 360X9X130 STER R H TROC NAIL 380X9X130 STER R H TROC NAIL 400X9X130 STER R H TROC NAIL 420X9X130 STER R H TROC NAIL 440X9X130 STER R H TROC NAIL 460X9X130 STER R H TROC NAIL 320X11X130 STER R H TROC NAIL 340X11X130 STER R H TROC NAIL 360X11X130 STER R H TROC NAIL 380X11X130 STER R H TROC NAIL 400X11X130 STER R H TROC NAIL 420X11X130 STER R H TROC NAIL 440X11X130 STER R H TROC NAIL 320X13X130 STER R H TROC NAIL 340X13X130 STER R H TROC NAIL 360X13X130 STER R H TROC NAIL 380X13X130 STER R H TROC NAIL 400X13X130 STER R H TROC NAIL 420X13X130 STER R H TROC NAIL 440X13X130 STER R H TROC NAIL 460X13X130 STER L H TROC NAIL 320X9X135 STER L H TROC NAIL 340X9X135 STER L H TROC NAIL 360X9X135 STER L H TROC NAIL 380X9X135 STER L H TROC NAIL 400X9X135 STER L H TROC NAIL 420X9X135 STER L H TROC NAIL 440X9X135 STER L H TROC NAIL 460X9X135 STER L H TROC NAIL 320X11X135 STER L H TROC NAIL 340X11X135 STER L H TROC NAIL 360X11X135 STER L H TROC NAIL 380X11X135 STER L H TROC NAIL 400X11X135 STER L H TROC NAIL 420X11X135 STER L H TROC NAIL 440X11X135 STER L H TROC NAIL 460X11X135 STER L H TROC NAIL 320X13X135 STER L H TROC NAIL 340X13X135 STER L H TROC NAIL 360X13X135 STER L H TROC NAIL 380X13X135 STER L H TROC NAIL 400X13X135 STER L H TROC NAIL 420X13X135 STER L H TROC NAIL 440X13X135 STER L H TROC NAIL 460X13X135 STER R H TROC NAIL 320X13X135 STER R H TROC NAIL 340X13X135 STER R H TROC NAIL 360X13X135 STER R H TROC NAIL 380X13X135 STER R H TROC NAIL 400X13X135 STER R H TROC NAIL 420X13X135 STER R H TROC NAIL 440X13X135 STER R H TROC NAIL 460X13X135 STER R H TROC NAIL 320X9X135 STER R H TROC NAIL 340X9X135 STER R H TROC

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Nov 9, 2017 Other Medical Devices View Details →

ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135 DEG X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →

AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE 800508345 NAIL TIB DYN 08X34.5 - STERILE 800508360 NAIL TIB DYN 08X36.0 - STERILE 800508375 NAIL TIB DYN 08X37.5 - STERILE 800508390 NAIL TIB DYN 08X39.0 - STERILE 800508405 NAIL TIB DYN 08X40.5 - STERILE 800508420 NAIL TIB DYN 08X42.0 - STERILE 800509255 NAIL TIB DYN 09X25.5 - STERILE 800509270 NAIL TIB DYN 09X27.0 - STERILE 800509285 NAIL TIB DYN 09X28.5 - STERILE 800509300 NAIL TIB DYN 09X30.0 - STERILE 800509315 NAIL TIB DYN 09X31.5 - STERILE 800509330 NAIL TIB DYN 09X33.0 - STERILE 800509345 NAIL TIB DYN 09X34.5 - STERILE 800509360 NAIL TIB DYN 09X36.0 - STERILE 800509375 NAIL TIB DYN 09X37.5 - STERILE 800509390 NAIL TIB DYN 09X39.0 - STERILE 800509405 NAIL TIB DYN 09X40.5 - STERILE 800509420 NAIL TIB DYN 09X42.0 - STERILE 800510255 NAIL TIB DYN 10X25.5 - STERILE 800510270 NAIL TIB DYN 10X27.0 - STERILE 800510285 NAIL TIB DYN 10X28.5 - STERILE 800510300 NAIL TIB DYN 10X30.0 - STERILE 800510315 NAIL TIB DYN 10X31.5 - STERILE 800510330 NAIL TIB DYN 10X33.0 - STERILE 800510345 NAIL TIB DYN 10X34.5 - STERILE 800510360 NAIL TIB DYN 10X36.0 - STERILE 800510375 NAIL TIB DYN 10X37.5 - STERILE 800510390 NAIL TIB DYN 10X39.0 - STERILE 800510405 NAIL TIB DYN 10X40.5 - STERILE 800510420 NAIL TIB DYN 10X42.0 - STERILE 800511270 NAIL TIB DYN 11X27.0 - STERILE 800511285 NAIL TIB DYN 11X28.5 - STERILE 800511300 NAIL TIB DYN 11X30.0 - STERILE 800511330 NAIL TIB DYN 11X33.0 - STERILE 800511345 NAIL TIB DYN 11X34.5 - STERILE 800511360 NAIL TIB DYN 11X36.0 - STERILE 800511375 NAIL TIB DYN 11X37.5 - STERILE 800511390 NAIL TIB DYN 11X39.0 - STERILE 800511405 NAIL TIB DYN 11X40.5 - STERILE 800511420 NAIL TIB DYN 11X42.0 - STERILE 800512270 NAIL TIB DYN 12X27.0 - STERILE 800512285 NAIL TIB DYN 12X28.5 - STERILE 800512300 NAIL TIB DYN 12X30.0 - STERILE 800512315 NAIL TIB DYN 12X31.5 - STERILE 800512330 NAIL TIB DYN 12X33.0 - STERILE 800512345 NAIL TIB DYN 12X34.5 - STERILE 800512360 NAIL TIB DYN 12X36.0 - STERILE 800512375 NAIL TIB DYN 12X37.5 - STERILE 800512390 NAIL TIB DYN 12X39.0 - STERILE 800512405 NAIL TIB DYN 12X40.5 - STERILE 800512420 NAIL TIB DYN 12X42.0 - STERILE 800513285 NAIL TIB DYN 13X28.5 - STERILE 800513300 NAIL TIB DYN 13X30.0 - STERILE 800513315 NAIL TIB DYN 13X31.5 - STERILE 800513330 NAIL TIB DYN 13X33.0 - STERILE 800513345 NAIL TIB DYN 13X34.5 - STERILE 800513360 NAIL TIB DYN 13X36.0 - STERILE 800513375 NAIL TIB DYN 13X37.5 - STERILE 800513390 NAIL TIB DYN 13X39.0 - STERILE 800513405 NAIL TIB DYN 13X40.5 - STERILE 800513420 NAIL TIB DYN 13X42.0 - STERILE Product Usage: A rod, when inserted into the intramedullary canal of the tibia, acts as an immobilization device to hold ends of a fractured bone in position.

Zimmer Biomet

Class I - Dangerous

The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.

Feb 6, 2018 Other Medical Devices View Details →

Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)

Johnson & Johnson Consumer

Class I - Dangerous

Johnson & Johnson Consumer Inc. is initiating a voluntary, Class II recall at the retail level in the U.S. of select COACH¿ Self-Adhering Sports Wraps, BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wraps and BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wraps products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.

Dec 18, 2017 Other Medical Devices View Details →

Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations.

Teleflex Medical

Class I - Dangerous

Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled.

Feb 15, 2018 Other Medical Devices View Details →

ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STERILE ATN LAG SCREW 80MM STERILE ATN LAG SCREW 85MM STERILE ATN LAG SCREW 90MM STERILE ATN LAG SCREW 95MM STERILE ATN LAG SCREW 100MM STERILE ATN LAG SCREW 105MM STERILE ATN LAG SCREW 110MM STERILE ATN LAG SCREW 115MM STERILE ATN LAG SCREW 120MM STERILE ATN LAG SCREW 125MM STERILE ATN LAG SCREW 130MM STERILE The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail System is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal nonunions and malunions and revision procedures.

Zimmer Biomet

Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the acceptance criteria for the DPR protocol for the ATN system.

Dec 20, 2017 Other Medical Devices Nationwide View Details →