Z-0529-2010

Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica...

Name: Z-0529-2010 Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-11-11
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-11-11 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33... on 2009-11-11. The reason FDA records is "Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0529-2010
Status: Terminated
Initiated: 2009-11-11
Posted: 2009-12-15
Terminated: 2010-08-30
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 33 mm size, One single unit to a package. Note: The 30 mm instruments were not distributed. The patella cutters are components of the Xcelerate Instruments and are used with additional devices to remove bone from the patella in preparation for a replacement implant. The Xcelerate Patella Reaming Instruments provide a means to prepare for implantation of either the Duracon or Scorpio Total Knee Systems patellar implants.
Product code: HTS Knife, Orthopedic
Reason for recall: Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.
Quantity in commerce: 12
Distribution: Nationwide Distribution (MA, NJ, FL, TN, OR and NY).
Product codes and lots: Catalog Number 8000-0033; Lot code V31257001.

Product code HTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)