FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF 8141-31-106, Depuy Orthopaedics, Inc., Warsaw, IN.
- Recall number
- Z-1582-2011
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 6 hole, Sterile, REF 8141-31-106, Depuy Orthopaedics, Inc., Warsaw, IN.
- Status
- Terminated
- Initiated
- 2010-11-01
- Posted
- 2011-03-07
- Terminated
- 2012-06-27
- 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.
- Lot, serial or model codes
- DLHCRB.
- 510(k) numbers
- ["K060969"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28