2 — Class II medical device recall Z-0323-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-12-02, distributed in AL, CA, CO, CT, FL, GA, IA, ID…. It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package
| Recall number | Z-0323-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-11-02 |
| Classified | 2015-11-20 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-07-15 |
| Distributed | 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 |
| Countries outside the US | CA |
| Quantity | 229 |
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 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 part is GP2615 (Modular Mini Fragment LCP System).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0323-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.