Drug recall
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been…
FDA recall event 71470 · Class II · Omnilife Science Inc.
Key facts
| Event ID | 71470 |
|---|---|
| Recall numbers | Z-2454-2015, Z-2455-2015 |
| Recalling firm | Omnilife Science Inc. |
| Product type | Devices |
| Products | Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip…, Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide… |
| Initiation date | Jun 9, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | Sep 28, 2015 |
| City | East Taunton |
| State | MA |
| Country | United States |
| FEI number | 3008342029 |
At a glance
- 1–9 Products in this recall
- 1–9 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: