2 — Class II medical device recall Z-0167-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-11-04, distributed in TN. Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
| Recall number | Z-0167-2016 |
|---|---|
| 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 | 2015-10-06 |
| Classified | 2015-10-27 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-07-15 |
| Distributed | TN |
| Quantity | 98 |
| Reason classes | labeling |
| Lot numbers | 3420620 |
| Model numbers | 202.212 |
Product
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
Reason for recall
Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
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-0167-2016. 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.