Recall Z-2036-2017 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
| Date | Apr 14, 2017 (initiated Mar 22, 2017) |
| Status | Terminated |
| Reason | This lot of left plates were laser etched and packaged as right plates. |
| Root cause | Mixed-up of materials/components |
| Action | Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700. |
| Quantity | 12 units |
| Distribution | Internationally to the country of : India |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092015 | PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM Smith & Nephew, Inc., Jul 30, 2009 |