Recall Z-1585-2011 ยท HRS Plate, Fixation, Bone
Depuy Orthopaedics, Inc.
POLYAX FEMORAL PLATE - LEFT, 15 hole, Sterile, REF 8141-31-115, Depuy Orthopaedics, Inc., Warsaw, IN.
| Date | Mar 7, 2011 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | The firm determined that the 8.0 mm hole threads in the PolyAx Distal Femoral Locking Plate were incorrectly manufactured, which prevents the mating screw from locking in place. The screw should lock with the plate, instead the screw passes through the plate. |
| Root cause | Other |
| Action | Urgent Information - Recall Notice letters, dated November 1, 2010 were sent to customers. The letters described the reason for recall and identified the product affected along with the affected units. The letters also provided clinical guidance and stated that the problem had been corrected and that DePuy was in the process of replenishing its inventory. Hospitals were to determine if any of the recalled components they received were still on hand, and return them immediately to their DePuy Representative or directly to DePuy for credit. |
| Quantity | 246 all products |
| Distribution | Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060969 | POLYAX LOCKED PLATING SYSTEM DePuy Orthopaedics, Inc., May 12, 2006 |