Device 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.
Z-1984-2014
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 68383
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44
- Official record key
device-enforcement:Z-1984-2014
Official wording
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.
Code information: All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
Distribution pattern: Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Derived failure modes
-
Labeling or packaging
mislabeling