Synthes B37 Replacement Screws — Class II medical device recall Z-1984-2014
Terminated recall by Synthes, Inc., reported 2014-07-09, distributed nationwide. All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not c
| Recall number | Z-1984-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-05-15 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 44 |
| Reason classes | labeling |
| Model numbers | 03.113.026, 3.113.025, 6350586, 6771518, 7086318, 7386422, 7523960, 7548937, B37 |
Product
Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Reason for recall
All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
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-1984-2014. 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.