Class 2 Device Recall TPS Drum

• Date Initiated by Firm: January 10, 2008
• Date Posted: April 22, 2008
• Recall Status: Terminated on December 01, 2009
• Recall Number: Z-1018-2008
• Recall Event ID: 46341
• 510(K)Number: K032303
• Product Classification: bone cutting tool - Product Code HBE
• Product: Stryker 10.5mm x 10.7mm Fluted Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-20-105.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Stryker Instruments Div. of Stryker Corporation; 4100 E. Milham Ave.; Portage MI 49002-9704
• For Additional Information Contact: 800-800-4236 Ext. 4056
• Manufacturer Reason for Recall: Lack of assurance of sterility.
• FDA Determined Cause: Package design/selection
• Action: Stryker sent a Medical Device Recall Notification letter dated 1/10/08 to consignees. The letter instructed them to check their facility for product, cease using it, and to return the product using a mailing label provided. International subsidiaries were notified via email.
• Quantity in Commerce: 10,588 of all products
• Distribution: Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.
• 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.

• 510(K) Database: 510(K)s with Product Code = HBE and Original Applicant = STRYKER INSTRUMENTS