PolyAx Locking Plate System, POLYAX FEMORAL PLATE - RIGHT, 6 hole, Sterile, REF 8141-30-106, Depuy Orthopaedics, Inc.Warsaw, IN.
FDA Recall Z-1578-2011 · Posted 2011-03-07
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Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2010-11-01
Date Terminated2012-06-27
Product Quantity246 all sizes
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- ME, MA, FL, VA, CO, TX, WY, AZ, MO, WI, GA, PA, AL, NY, OH, NJ, NC, and CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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