Drug recall
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
FDA recall event 70438 · Class II · Biomet, Inc.
Key facts
| Event ID | 70438 |
|---|---|
| Recall numbers | Z-1122-2015, Z-1123-2015 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc), Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two. |
| Initiation date | Jan 9, 2015 |
| Report date | Feb 25, 2015 |
| Termination date | Oct 22, 2015 |
| 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: