Synthes Guide Blocks for the 2 Column Plate 6 Hole Head — Class II medical device recall Z-2087-2014
Terminated recall by Synthes, Inc., reported 2014-07-30, distributed nationwide. The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labele
| Recall number | Z-2087-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-05-29 |
| Classified | 2014-07-21 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM |
| Quantity | 180 |
| Reason classes | labeling |
| Lot numbers | 10-5147 |
| Model numbers | 03.111.600, 03.111.601 |
Product
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Reason for recall
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.
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-2087-2014. 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.