Drug recall
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture…
FDA recall event 80048 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 80048 |
|---|---|
| Recall numbers | Z-1916-2018 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely. |
| Initiation date | May 4, 2018 |
| Report date | May 30, 2018 |
| Termination date | Oct 21, 2019 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3008812560 |
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: