FDA Device recall Z-1754-2015
Mallory/Head Primary Hip System
- FDA Device
- Class III
- terminated
- Published 2015-06-17
On 2015-06-17 the FDA classified a Class III recall of Mallory/Head Primary Hip System by Biomet, citing biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1754-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-16 |
| Published | 2015-06-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
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
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Identifiers
| code_info | Part Numbers: 11-104212 & 11-104211;Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1754-2015%22
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