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.
FDA Recall Z-1984-2014 · Posted 2014-07-02
Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2014-05-15
Date Terminated2015-12-18
Product Quantity44
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.
Firm Action
An urgent medical device recall notice, dated May 29, 2014, was sent to end users and sales consultants to advise them of the issue and provide instructions for returning affected devices.
Root Cause
Labeling design
Distribution Pattern
Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.