Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- January 11, 2013
- Posted
- April 5, 2013
- Terminated
- August 31, 2015
- Recall Number
- Z-1062-2013
- Quantity
- 328
- Firm Location
- West Chester, PA
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.
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.
Lot / Code Info
Part number 355.28, all lot numbers
Root Cause
Device Design
Action Taken
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.