Class 2 Device Recall OrthoTec

• Date Initiated by Firm: November 12, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on May 03, 2004
• Recall Number: Z-0171-04
• Recall Event ID: 27690
• Product Classification: Tubing, Fluid Delivery - Product Code FPK
• Product: Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
• Code Information: Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.
• Recalling Firm/ Manufacturer: Stryker Instruments, Instruments Div.; 4100 E. Milham; Kalamazoo MI 49001
• For Additional Information Contact: Becky Ditty; 800-800-4236 Ext. 3434
• Manufacturer Reason for Recall: Product sterility may have been compromised by an inadequate package seal.
• FDA Determined Cause: Other
• Action: Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product.
• Quantity in Commerce: 15
• Distribution: United States, France and United Kingdom.
• 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.