Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
FDA Recall Z-1062-2013 · Posted 2013-04-05
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-01-11
Date Terminated2015-08-31
Product Quantity328
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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