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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Flexible Grip

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  Class 2 Device Recall Synthes Flexible Grip see related information
Date Initiated by Firm January 11, 2013
Date Posting Updated April 05, 2013
Recall Status1 Terminated 3 on August 31, 2015
Recall Number Z-1062-2013
Recall Event ID 64200
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Flexible Grip which is part of the Synthes Universal Nail System.

Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Code Information Part number 355.28, all lot numbers
Recalling Firm/
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
FDA Determined
Cause 2
Device Design
Action Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter requested consignees examine inventory, remove the recalled products from use and return them to Synthes. If you have any questions, contact the firm at 610-719-5450.
Quantity in Commerce 328
Distribution Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.
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.