Drug recall
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and…
FDA recall event 69851 · Class II · Zimmer Manufacturing B.V.
Key facts
| Event ID | 69851 |
|---|---|
| Recall numbers | Z-0824-2015 |
| Recalling firm | Zimmer Manufacturing B.V. |
| Product type | Devices |
| Products | Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. . |
| Initiation date | Nov 21, 2014 |
| Report date | Dec 24, 2014 |
| Termination date | Aug 10, 2015 |
| FEI number | 1000132037 |
At a glance
- 1–9 Products in this recall
- 10–99 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: