Drug recall
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade…
FDA recall event 66421 · Class II · Synthes USA HQ, Inc.
Key facts
| Event ID | 66421 |
|---|---|
| Recall numbers | Z-0387-2014 |
| Recalling firm | Synthes USA HQ, Inc. |
| Product type | Devices |
| Products | Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. |
| Initiation date | Jul 31, 2013 |
| Report date | Dec 4, 2013 |
| Termination date | Jun 1, 2015 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3005180112 |
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: