Recall Z-1082-2007 ยท GDF Guide, Needle, Surgical
Synovis Surgical Inovation Div. of
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4-15GPS . Sterile, One Time Use, Contents 4 sets 1- suture passer instrument, 1-guide rod, 15 mm, 250 mm long. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W.,
| Date | Jul 24, 2007 (initiated Jun 19, 2007) |
| Status | Terminated |
| Reason | There is a potential for the pouch to become damaged during shipping, compromising the sterility of the device inside. |
| Root cause | Other |
| Action | 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. |
| Quantity | 1box (4 units) |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.