Class 2 Device Recall Reamer THandle

• Date Initiated by Firm: August 08, 2005
• Date Posted: February 17, 2010
• Recall Status: Terminated on February 18, 2010
• Recall Number: Z-0793-2010
• Recall Event ID: 50099
• Product Classification: Orthopedic manual surgical instrument - Product Code HTO
• Product: Reamer T-Handle; Non- Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.
• Code Information: Catalog Number: 1101-2100; Lot Codes: SZK01, SZK02, SZK03, SZK06 and SZL01.
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Rita Intorella; 201-972-2100
• Manufacturer Reason for Recall: Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
• FDA Determined Cause: Device Design
• Action: Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.
• Quantity in Commerce: 273
• Distribution: Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.
• 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.