Drug recall
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large…
FDA recall event 64159 · Class II · Synthes USA HQ, Inc.
Key facts
| Event ID | 64159 |
|---|---|
| Recall numbers | Z-0941-2013 |
| Recalling firm | Synthes USA HQ, Inc. |
| Product type | Devices |
| Products | Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. |
| Initiation date | Jan 11, 2013 |
| Report date | Mar 20, 2013 |
| Termination date | Aug 31, 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
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Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: