Recall archive / FDA device enforcement
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total h... — FDA record Z-1294-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 27, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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
- Classification
- Class II
- Recalling firm
- Zimmer, Inc.
- Quantity
- 1,168 untits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1294-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN Number: 00889024283268 All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AL AZ CO FL LA MI OH OK TX Foreign: Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 5, 2023
- Recall initiation date
- Feb 27, 2023
- Center classification date
- Mar 29, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.