| | Class 2 Recall
Pulsavac |  |
| Date Posted |
March 06, 2008 |
| Recall Number |
Z-0856-2008 |
| 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
|
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.
|
| 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 |
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