Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Zimmer Pulsavac Wound Debridement System high capacity intramedullary brush tip		see related information
Date Posted July 23, 2009
Recall Number Z-1698-2009
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
Reason for
Recall		 The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
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.
 
-
-