Class 2 Device Recall Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip

• Date Initiated by Firm: June 08, 2009
• Date Posted: July 23, 2009
• Recall Status: Terminated on December 15, 2009
• Recall Number: Z-1698-2009
• Recall Event ID: 52227
• Product Classification: Lavage, jet - Product Code FQH
• Product: Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip, sterile, Zimmer, Dover, Ohio; Catatog Number: 00515018300. Used in conjunction with the Pulsavac Plus Wound Debridement System for pulsatile lavage/debridement.
• Code Information: Lot Number: 61229259.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 330-364-0980
• Manufacturer Reason for Recall: The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
• FDA Determined Cause: Packaging process control
• Action: Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.
• Quantity in Commerce: 15
• Distribution: Worldwide Distribution -- United States, Canada and Japan.
• 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.