—#86691

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.

FDA product code: HTS — Knife, Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 8000-0033; Lot code V31257001.

Why it was recalled

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 (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution (MA, NJ, FL, TN, OR and NY).

Timeline

Recall initiated: 2009-11-11
Posted by FDA: 2009-12-15
Terminated: 2010-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86691. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.