| Class 2 Device Recall Pulsavac | |
Date Initiated by Firm | December 18, 2007 |
Date Posted | March 06, 2008 |
Recall Status1 |
Terminated 3 on May 03, 2012 |
Recall Number | Z-0859-2008 |
Recall Event ID |
46206 |
Product Classification |
Jet Lavage - Product Code FQH
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Product | Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio |
Code Information |
Lot Numbers: 60626637, 60652433, 60671457, 60693320, 60698948, 60708439, 60715492, and 60725499 |
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 | 9,411 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 |
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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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