—#96198

Product

PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 9 hole, Sterile, REF 8141-31-109, Depuy Orthopaedics, Inc., Warsaw, IN.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060969
Affected lot / code info: DLHCRC.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA.

Timeline

Recall initiated: 2010-11-01
Posted by FDA: 2011-03-07
Terminated: 2012-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96198. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.