| Class 2 Device Recall Zimmer Dermacarriers II | |
Date Initiated by Firm | April 03, 2008 |
Date Posted | July 30, 2008 |
Recall Status1 |
Terminated 3 on December 17, 2009 |
Recall Number | Z-1550-2008 |
Recall Event ID |
47334 |
Product Classification |
Skin Graft Expander - Product Code FZW
|
Product | Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-2195-012-00.
Single use device for use during skin grafting procedures. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | 330-343-8801 |
Manufacturer Reason for Recall | Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end. |
FDA Determined Cause 2 | Packaging process control |
Action | Consignees were notified via letter (Urgent: Medical Device Correction) dated 4/3/08 to identify their stocks on hand, verify package sealing, to discard any non-sealed packages, mail the Business Reply Card regardless if there are any remaining affected products. |
Quantity in Commerce | 99345 of all units |
Distribution | Worldwide Distribution --- including USA and countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, Ecuador, England, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Largos, Lebanon, Lithuania, Malta, Mexico, Morocco, Netherlands, Nigeria, Panama, Peru, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela. |
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.
|
|
|
|