Prosthesis, Hip, Hemi-, Femoral, Metal

UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty.

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty.

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty.

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9

Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).

CORAIL HIGH OFFSET STEM Collarless SIZE 14

Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).

Corin Unipolar Adapter Sleeve, For use with Corin Unipolar CoCr Heads; Not for use w/ceramic heads; not for use w/ Stainless Steel implants.

The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-compliance issue. however, poor process controls demonstrated by this vendor has raised concern about their supplied raw material. As a precaution and due to the potential impact on the mechanical properties of the products, St

Omniflex-HA Hip Stem W/C Taper.

Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430

Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.