FDA Device recall Z-0323-2016
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm by Synthes Usa Products, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0323-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-02 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | AL, CA, CO, CT, FL, GA, IA, ID, IN, KS, MA, MD, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, WV |
Product
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 in osteopenic bone.
Reason
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 part is GP2615 (Modular Mini Fragment LCP System).
Identifiers
| code_info | Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0323-2016%22
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