Drug recall
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and…
FDA recall event 66412 · Class II · Synthes USA HQ, Inc.
Key facts
| Event ID | 66412 |
|---|---|
| Recall numbers | Z-0408-2014 |
| Recalling firm | Synthes USA HQ, Inc. |
| Product type | Devices |
| Products | Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery. |
| 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: