Recall Z-1062-2013 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
| Date | Apr 5, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.