Class 2 Device Recall Synthes B37 Replacement Screws

• Date Initiated by Firm: May 15, 2014
• Date Posted: July 02, 2014
• Recall Status: Terminated on December 18, 2015
• Recall Number: Z-1984-2014
• Recall Event ID: 68383
• Product Classification: Screw, for manual surgical instrument - Product Code HWC
• 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.
• Code Information: All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
• Recalling Firm/ Manufacturer: Synthes, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Customer Support; 610-719-5000
• Manufacturer 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.
• FDA Determined Cause: Labeling design
• 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.
• Quantity in Commerce: 44
• Distribution: Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.