Mallory/Head Primary Hip System — Class III medical device recall Z-1754-2015
Terminated recall by Biomet, Inc., reported 2015-06-17, distributed nationwide. Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN
| Recall number | Z-1754-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-04-16 |
| Classified | 2015-06-10 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, CN, JP, KR, MX, NZ, TH, TT |
| Quantity | 1,315 |
| Reason classes | labeling |
| Lot numbers | 127340, 182030, 349650 |
| Model numbers | 11-104211, 11-104212 |
| Expiration dates | 2025-03-18 |
Product
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Reason for recall
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
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-1754-2015. 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.