Z-1584-2011

PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy...

Name: Z-1584-2011 PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy...
Creator: Depuy Orthopaedics, Inc.
Published: 2010-11-01
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2010-11-01 / Terminated / root cause: manufacturing process

FDA source

Depuy Orthopaedics, Inc. began a recall of PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy Orthopaedics, Inc., Warsaw, IN on 2010-11-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1584-2011
Status: Terminated
Initiated: 2010-11-01
Posted: 2011-03-07
Terminated: 2012-06-27
Recalling firm: Depuy Orthopaedics Inc.
Product: PolyAx Locking Plate System, POLYAX FEMORAL PLATE - LEFT, 12 hole, Sterile, REF 8141-31-112, Depuy Orthopaedics, Inc., Warsaw, IN.
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: DLHBGZ, DLHCRD, DLIB44.

Product code HRS

K060969Class IIPolyax Locked Plating SystemDePuy Orthopaedics, Inc. / cleared 2006-05-12

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)