Drug recall
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision…
FDA recall event 72741 · Class II · Biomet, Inc.
Key facts
| Event ID | 72741 |
|---|---|
| Recall numbers | Z-0450-2016 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud… |
| Initiation date | Nov 20, 2015 |
| Report date | Dec 30, 2015 |
| Termination date | Sep 8, 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: