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U.S. Department of Health and Human Services

Class 2 Device Recall Pulsavac

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 Class 2 Recall
Pulsavac
see related information
Date Posted March 06, 2008
Recall Status1 Open
Recall Number Z-0856-2008
Recall Event ID 46206
Product Classification Lavage, Jet - Product Code FQH
Product Pulsavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-420-00,10 kits/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio
Code Information Lot Numbers: 60613025, 60617428, 60622532, 60626631, 60629996, 60633951, 60640534, 60650384, 60652419, 60656841, 60661592, 60661594, 60666491, 60666492, 60671448, 60671449, 60676102, 60693310, 60693311, 60693314, 60693315, 60693326, 60693327, 60694265, 60694266, 60698941, 60703269, 60709912, 60715481, 60723866, 60725488, 60733552, 60733553, 60737816, 60737817, 60739957, 60739958, 60744533, 60744534, 60750514, 60750515, and 60758733
Recalling Firm/
Manufacturer
Zimmer Orthopaedic Surgical Products
200 W Ohio Ave
Dover, Ohio 44622-9642
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Joyce Elkins
330-364-9483
Manufacturer Reason
for Recall
Sterility (package integrity) compromised; The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Zimmer notified their customers via an Urgent Device Recall letter dated January 8, 2008. The letter requests each customers to inventory their stock. If any recalled product is located the customer is to notify Zimmer via fax and a replacement part will be shipped to them.
Quantity in Commerce 4,921 Kits
Distribution Worldwide-USA, forty-two international and one Canadian account, including countries of Singapore, Hong Kong, Lebanon, Finland, Australia, Japan, Israel, Korea, Saudi Arabia, Dubai, Denmark, Czech Republic, Guatemala, Brazil, Taiwan, China, Nicaragua, Virgin Island, Switzerland, Austria, Spain, Belgium, The Netherlands, France, Germany, Portugal, England, Sweden, India, Argentina, Italy, Chile, Thailand & Saudi Arabia
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.
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