Synthes 5 — Class II medical device recall Z-1125-2014
Terminated recall by Synthes, Inc., reported 2014-03-12, distributed nationwide. Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cer
| Recall number | Z-1125-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-02-05 |
| Classified | 2014-03-04 |
| Reported by FDA | 2014-03-12 |
| Terminated | 2015-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 45 |
| Reason classes | labeling |
| Lot numbers | 823111 |
| Model numbers | 02.231.240 |
Product
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
Reason for recall
Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).
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-1125-2014. 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.