smith&nephew Mini-Fragment Plating System — Class II medical device recall Z-0397-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-01-31, distributed in GA, MI, OH. Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STO
| Recall number | Z-0397-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2017-12-11 |
| Classified | 2018-01-19 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2018-06-22 |
| Distributed | GA, MI, OH |
| Quantity | 2 units |
| Reason classes | labeling |
| Lot numbers | 16KM10662C |
| Model numbers | 74442030 |
Product
smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Reason for recall
Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
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-0397-2018. 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.