CoCr Femoral Head hip implant compatibility removed due to motion limitations
Zimmer is updating the compatibility matrix for the CoCr Femoral Head XS hip implant to remove pairing with Epsilon Durasul Constrained Acetabular Liners due to insufficient range of motion in flexion/extension.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a hip implant compatibility issue. The CoCr Femoral Head XS provides insufficient range of motion when paired with specific acetabular liners, falling below the ISO 21535:2009 standard. This represents a risk-of-harm product where injury has not yet been reported, fitting the Score 3 criterion.
Plain-English summary
Zimmer, Inc. is updating the Instructions for Use (IFU) compatibility matrix for the CoCr Femoral Head XS (Item Number 01.01012.384), a modular head component used in total hip arthroplasty. Approximately 1,168 units have been distributed in the United States (Alabama, Arizona, Colorado, Florida, Louisiana, Michigan, Ohio, Oklahoma, and Texas) and Canada.
The update removes the compatibility pairing between the CoCr Femoral Head XS and the Epsilon Durasul Constrained Acetabular Liners. This change is due to insufficient range of motion when these components are used together: the flexion/extension motion is less than 100 degrees, which falls below the 100-degree minimum recommended by the international standard ISO 21535:2009.
Healthcare providers should verify component compatibility before performing hip replacement procedures and refer to the updated IFU when selecting all component pairings. Patients with questions about their hip replacement should consult their surgeon.
The recalled product
- Product
- 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
- Manufacturer
- Zimmer, Inc.
- Hazard
- device-incompatibility
- reduced-range-of-motion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN Number: 00889024283268 All lots
Distribution
Distributed in 9 states:
- AL
- AZ
- CO
- FL
- LA
- MI
- OH
- OK
- TX
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