Metasul Femoral Head — Class II medical device recall Z-1133-2015
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-1133-2015 |
|---|---|
| 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 | 30 |
| Reason classes | sterility |
| Lot numbers | 2553420, 2556039, 2560585, 2560586, 2563398 |
| Model numbers | 19.32.05 |
Product
Metasul 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-1133-2015. 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.