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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes B37 Replacement Screws

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  Class 2 Device Recall Synthes B37 Replacement Screws see related information
Date Initiated by Firm May 15, 2014
Date Posted July 02, 2014
Recall Status1 Terminated 3 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 2		 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.
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