FDA Device recall Z-1949-2016
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile
- FDA Device
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile by Synthes Usa Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1949-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-02 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | CO |
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
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.
Identifiers
| code_info | Lot Number 9890811, Catalog ID 02.110.115S |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1949-2016%22
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