Class 2 Device Recall Stryker Orthopaedics Sterile Knee Instrument Disposable Patella Cutter

• Date Initiated by Firm: November 11, 2009
• Date Posted: December 15, 2009
• Recall Status: Terminated on August 30, 2010
• Recall Number: Z-0529-2010
• Recall Event ID: 53858
• Product Classification: Patella Cutter - Product Code HTS
• 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.
• Code Information: Catalog Number 8000-0033; Lot code V31257001.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Rose Mincieli; 201-831-5832
• Manufacturer 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.
• FDA Determined 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).
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.