Recall Z-0373-2016 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate
| Date | Dec 4, 2015 (initiated Oct 20, 2015) |
| Status | Terminated |
| Reason | The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates. |
| Root cause | Employee error |
| Action | Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it. |
| Quantity | 9 units |
| Distribution | International only Germany, Japan, Russia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083032 | PERI-LOC BONE PLATING AND SCREW SYSTEM Smith & Nephew, Inc., Jan 7, 2009 |