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U.S. Department of Health and Human Services

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

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 Class 2 Recall
Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip
see related information
Date Posted July 23, 2009
Recall Status1 Terminated on December 15, 2009
Recall Number Z-1698-2009
Recall Event ID 52227
Premarket Notification
510(K) Numbers
K001733  K040389 
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, Indiana 46580-2746
Manufacturer Reason
for Recall
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FQH and Original Applicant = ZIMMER, INC.
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