LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile — Class II medical device recall Z-1949-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-06-22, distributed in CO. Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius
| Recall number | Z-1949-2016 |
|---|---|
| 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 | 2016-05-02 |
| Classified | 2016-06-10 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-12-09 |
| Distributed | CO |
| Quantity | 6 units |
| Reason classes | labeling |
| Lot numbers | 9890811 |
| Model numbers | 02.110.115S |
Product
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Reason for recall
Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.
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-1949-2016. 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.