Class 3 Device Recall Stayfuse

• Date Initiated by Firm: January 20, 2004
• Date Posted: February 27, 2004
• Recall Status: Terminated on May 20, 2004
• Recall Number: Z-0561-04
• Recall Event ID: 28213
• 510(K)Number: K990804
• Product Classification: Screw, Fixation, Bone - Product Code HWC
• Product: Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.
• Code Information: Lot 77097300.
• Recalling Firm/ Manufacturer: Pioneer Surgical Technology; 375 River Park Cir; Marquette MI 49855-1781
• For Additional Information Contact: Dan Nelson; 906-226-4489
• Manufacturer Reason for Recall: Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
• FDA Determined Cause: Other
• Action: Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.
• Quantity in Commerce: 318
• Distribution: By Zimmer: Nationwide, Australia, Canada, Germany 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.

• 510(K) Database: 510(K)s with Product Code = HWC