Recall Z-0941-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Synthes USA HQ, Inc.
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
| Date | Mar 11, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. |
| Root cause | Nonconforming Material/Component |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email FieldAction@synthes.com |
| Quantity | 136 |
| Distribution | USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082650 | SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL Synthes (Usa), Nov 18, 2008 |