Drug recall
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue…
FDA recall event 71526 · Class II · Biomet, Inc.
Key facts
| Event ID | 71526 |
|---|---|
| Recall numbers | Z-1944-2015, Z-1945-2015 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures., Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the… |
| Initiation date | Jun 3, 2015 |
| Report date | Jul 8, 2015 |
| Termination date | Dec 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: