FDA Device recall Z-2087-2014
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System)
- FDA Device
- Class II
- terminated
- Published 2014-07-30
On 2014-07-30 the FDA classified a Class II recall of Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) by Synthes, citing the Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2087-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-29 |
| Published | 2014-07-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
Product
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Reason
The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct.
Identifiers
| code_info | part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2087-2014%22
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