PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 9 hole, Sterile, REF 8141-30-109, Depuy Orthopaedics, Inc., W
FDA device recall Z-1587-2011 · posted 2011-03-07 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 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.
- Date initiated
- 2010-11-01
- Date posted
- 2011-03-07
- Date terminated
- 2012-06-27
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POLYAX LOCKED PLATING SYSTEM (K060969) | DePuy Orthopaedics, Inc. | 2006-05-12 |