Other Medical Devices Recalls

Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404, 38014435, 38014600, 38014604, 38014635, 38014800, 38014804, 38014835, 38015000, 38015004, 38015035, 38015200, 38015204, 38015235, 38015400, 38015404, 38015435, 38015600, 38015604, 38015635, 38AC3600, 38AC3800, 38AC4000, 38AC4200, 38AC4400, 38AC4600, 38AC4800, 38AC5000, 38AC5200, 38AC5400, 38AC5600, 38AM3600, 38AM3604, 38AM3635, 38AM3800, 38AM3804, 38AM3835, 38AM4000, 38AM4004, 38AM4035, 38AM4200, 38AM4204, 38AM4235, 38AM4400, 38AM4404, 38AM4435, 38AM4600, 38AM4604, 38AM4635, 38AM4800, 38AM4804, 38AM4835, 38AM5000, 38AM5004, 38AM5035, 38AM5200, 38AM5204, 38AM5235, 38AM5400, 38AM5404, 38AM5435, 38AM5600, 38AM5604, 38AM5635, PL38HM4400, PL38HM4404, PL38HM4435, PL38HM4600, PL38HM4604, PL38HM4635, PL38HM4800, PL38HM4804, PL38HM4835, PL38HM5000, PL38HM5004, PL38HM5035, PL38HM5200, PL38HM5204, PL38HM5235

MicroPort Orthopedics

Class I - Dangerous

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Jun 21, 2016 Other Medical Devices Nationwide View Details →

Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

Merge Healthcare

Class I - Dangerous

Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

Jan 30, 2016 Other Medical Devices Nationwide View Details →

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

Terumo BCT

Class I - Dangerous

Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.

Nov 3, 2016 Other Medical Devices Nationwide View Details →

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Synthes (USA) Products

Class I - Dangerous

Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

Nov 1, 2016 Other Medical Devices Nationwide View Details →

Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head

MicroPort Orthopedics

Class I - Dangerous

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Jun 21, 2016 Other Medical Devices Nationwide View Details →

FMsealer Open Shears. Model FM3001

Domain Surgical

Class I - Dangerous

Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.

Oct 24, 2016 Other Medical Devices Nationwide View Details →

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

Teleflex Medical

Class I - Dangerous

Sterility: Due to a potential incomplete seal on the outer sterile package.

Nov 8, 2016 Other Medical Devices Nationwide View Details →

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Elekta

Class I - Dangerous

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

Nov 17, 2016 Other Medical Devices Nationwide View Details →

Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Elekta

Class I - Dangerous

Incorrect Dose when using the reset function.

Nov 3, 2016 Other Medical Devices Nationwide View Details →

Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864, REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058, REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852, REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672 For use with the conserve metal head

MicroPort Orthopedics

Class I - Dangerous

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Jun 21, 2016 Other Medical Devices Nationwide View Details →

Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664 For use with the conserve metal head

MicroPort Orthopedics

Class I - Dangerous

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Jun 21, 2016 Other Medical Devices Nationwide View Details →

Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head

MicroPort Orthopedics

Class I - Dangerous

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Jun 21, 2016 Other Medical Devices Nationwide View Details →

MISAGO RX Self Expanding Peripheral Stem

Terumo Medical

Class I - Dangerous

During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

Aug 4, 2016 Other Medical Devices Nationwide View Details →

Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head

MicroPort Orthopedics

Class I - Dangerous

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.

Jun 21, 2016 Other Medical Devices Nationwide View Details →

ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours

Sorin Group USA

Class I - Dangerous

On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).

Aug 1, 2014 Other Medical Devices Nationwide View Details →

ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

Teleflex Medical

Class I - Dangerous

Sterility: Due to a potential incomplete seal on the outer sterile package.

Nov 8, 2016 Other Medical Devices Nationwide View Details →

Extraction Hook - Sterile for TI Cannulated Nails

Synthes (USA) Products

Class I - Dangerous

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Oct 3, 2016 Other Medical Devices Nationwide View Details →

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

Synthes (USA) Products

Class I - Dangerous

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Oct 3, 2016 Other Medical Devices Nationwide View Details →

3.0 mm Reaming Rod/950 mm, Sterile

Synthes (USA) Products

Class I - Dangerous

The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Oct 3, 2016 Other Medical Devices Nationwide View Details →

Philips Healthcare System X-ray Tomography Computed :

Philips Electronics North America

Class I - Dangerous

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

Mar 15, 2016 Other Medical Devices Nationwide View Details →