Drug recall
Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
FDA recall event 72521 · Class II · Biomet, Inc.
Key facts
| Event ID | 72521 |
|---|---|
| Recall numbers | Z-0650-2016 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | PMMA is listed as a material on the label but the product does not contain PMMA. |
| Initiation date | Nov 17, 2015 |
| Report date | Jan 20, 2016 |
| Termination date | Jul 5, 2016 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: