Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-10GPS. Sterile, One Time Use,
FDA device recall Z-1080-2007 · posted 2007-07-24 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Inovation Div. of
- Reason for recall
- There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside.
- Action taken
- Consignees were sent a letter on June 19, 2007. The letter identified the product and problem. The letter also included a form for inventory purposes which is to be completed and faxed to Synovis.
- Root cause
- Other
- Status
- Terminated
- Product code
- GDF
- Quantity affected
- 2 boxes (8 units)
- Distribution
- Nationwide.
- Date initiated
- 2007-06-19
- Date posted
- 2007-07-24
- Date terminated
- 2012-05-08
- Location
- Saint Paul, MN
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