CoCr Femoral Head — Class II medical device recall Z-1132-2015
Terminated recall by Zimmer Gmbh, reported 2015-03-04, distributed in AK, AL, AR, AZ, CA, CT, DE, FL…. Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may resu
| Recall number | Z-1132-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Gmbh, Winterthur, N/A, Switzerland |
| Recall initiated | 2014-12-17 |
| Classified | 2015-02-20 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2015-09-23 |
| Distributed | AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY |
| Countries outside the US | CA, JP |
| Quantity | 1,908 |
| Reason classes | sterility |
| Lot numbers | 2539887, 2539888, 2540911, 2540926, 2542690, 2542691, 2542692, 2542693, 2543993, 2544892, 2544893, 2544894, 2544895, 2544896, 2545830, 2545831, 2545832, 2545833, 2547043, 2547044, 2547807, 2548952, 2548953, 2548954, 2551330, 2551762, 2551860, 2551861, 2551930, 2551931, 2551932, 2553210, 2553419, 2554798, 2554799, 2554800, 2556029, 2557054, 2558475, 2558476 and 28 more |
| Model numbers | 01.01012.384 |
Product
CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
Reason for recall
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1132-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.