Other Medical Devices Recalls

Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small/2MM Step/Left (002-C-01002L); f) Small/2MM Step/Right (002-C-01002R); g) Large/2MM Step/Left (002-C-02002L); h) Large/2MM Step/Right (002-C-02002R)

Orthofix

Class I - Dangerous

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Apr 6, 2018 Other Medical Devices View Details →

Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.

Hobbs Medical

Class I - Dangerous

Device was marketed for uses outside the 510(k) clearance.

May 1, 2018 Other Medical Devices Nationwide View Details →

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Datascope

Class I - Dangerous

There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

Mar 11, 2016 Other Medical Devices View Details →

CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)

Orthofix

Class I - Dangerous

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Apr 6, 2018 Other Medical Devices View Details →

ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)

Orthofix

Class I - Dangerous

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Apr 6, 2018 Other Medical Devices View Details →

ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)

Orthofix

Class I - Dangerous

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Apr 6, 2018 Other Medical Devices View Details →

ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems

Siemens Healthcare Diagnostics

Class I - Dangerous

Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results cannot be generated by the system when calibration fails.

Mar 27, 2018 Other Medical Devices Nationwide View Details →

11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

Ii - Vi Incorporated

Class I - Dangerous

Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.

Dec 13, 2017 Other Medical Devices View Details →

ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →

Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)

Orthofix

Class I - Dangerous

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Apr 6, 2018 Other Medical Devices View Details →

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983

Becton Dickinson & Company

Class I - Dangerous

Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube

Feb 13, 2018 Other Medical Devices Nationwide View Details →

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

Datascope

Class I - Dangerous

There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.

Mar 11, 2016 Other Medical Devices View Details →

Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020) g) D 3.2MM X 22MM (002-E-32022) h) D 3.2MM X 24MM (002-E-32024) i) D 3.2MM X 26MM (002-E-32026) j) D 3.2MM X 28MM (002-E-32028) k) D 3.2MM X 30MM (002-E-32030) l) D 3.2MM X 32MM (002-E-32032) m) D 3.2MM X 34MM (002-E-32034) n) D 3.2MM X 36MM (002-E-32036) o) D 3.2MM X 38MM (002-E-32038) p) D 3.2MM X 40MM (002-E-32040) q) D 3.2MM X 42MM (002-E-32042) r) D 3.2MM X 44MM (002-E-32044) s) D 3.2MM X 46MM (002-E-32046) t) D 3.2MM X 48MM (002-E-32048) u) D 3.2MM X 50MM (002-E-32050)

Orthofix

Class I - Dangerous

Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.

Apr 6, 2018 Other Medical Devices View Details →

Restoris MCK Onlay Insert Extractor.

Mako Surgical

Class I - Dangerous

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

Jan 19, 2018 Other Medical Devices Nationwide View Details →

ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid

Tosoh Bioscience

Class I - Dangerous

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

Mar 5, 2018 Other Medical Devices Nationwide View Details →