Biolox Delta Femoral Head — Class II medical device recall Z-1134-2015
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-1134-2015 |
|---|---|
| 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 | 10,340 |
| Reason classes | sterility |
| Lot numbers | 2522713, 2522849, 2524199, 2524200, 2524201, 2524202, 2524203, 2524204, 2524205, 2524241, 2524242, 2524244, 2524260, 2524261, 2524262, 2524263, 2524271, 2524272, 2527529, 2527535, 2527536, 2527537, 2527538, 2527539, 2527546, 2527547, 2527548, 2527549, 2527590, 2527592, 2527593, 2527594, 2527606, 2531222, 2531774, 2531815, 2531816, 2531817, 2531818, 2531819 and 211 more |
| Model numbers | 00-8775-028-01 |
Product
Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.
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-1134-2015. 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.