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U.S. Department of Health and Human Services

Class 2 Device Recall Pulsavac

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  Class 2 Device Recall Pulsavac see related information
Date Initiated by Firm December 18, 2007
Date Posting Updated March 06, 2008
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0856-2008
Recall Event ID 46206
Product Classification Jet Lavage - 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 OH 44622-9642
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
Other
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 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.
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