Recall Z-0408-2014 ยท HTW Bit, Drill
Synthes USA HQ, Inc.
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
| Date | Nov 27, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery. |
| Root cause | Device Design |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450. |
| Quantity | 166 |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.