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CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for art...

FDA Recall #Z-1294-2023 — Class II — February 27, 2023

Recall #Z-1294-2023 Date: February 27, 2023 Classification: Class II Status: Ongoing

Product Description

CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384

Reason for Recall

Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009

Recalling Firm

Zimmer, Inc. — Warsaw, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

1,168 untits

Distribution

AL AZ CO FL LA MI OH OK TX Foreign: Canada

Code Information

GTIN Number: 00889024283268 All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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