FDA Device recall Z-1984-2014
Synthes B37 Replacement Screws
- FDA Device
- Class II
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class II recall of Synthes B37 Replacement Screws by Synthes, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1984-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-15 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937. |
|---|
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-1984-2014%22
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