Recall Z-2086-2015 ยท FZO Chisel, Surgical, Manual
Synthes (USA) Products LLC
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
| Date | Jul 16, 2015 (initiated Jun 24, 2015) |
| Status | Terminated |
| Reason | It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. |
| Root cause | Employee error |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant. |
| Quantity | 100 |
| Distribution | US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.