Drug recall
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies…
FDA recall event 72553 · Class II · Synthes (USA) Products LLC
Key facts
| Event ID | 72553 |
|---|---|
| Recall numbers | Z-0323-2016 |
| Recalling firm | Synthes (USA) Products LLC |
| Product type | Devices |
| Products | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above… |
| Initiation date | Nov 2, 2015 |
| Report date | Dec 2, 2015 |
| Termination date | Jul 15, 2016 |
| 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: