| Date Initiated by Firm | December 11, 2002 |
|---|
| Create Date | June 25, 2015 |
|---|
| Recall Status1 |
Terminated 3 on May 28, 2003 |
| Recall Number | Z-0352-03 |
|---|
| Recall Event ID |
25226 |
| 510(K)Number | K002233 |
|---|
| Product Classification |
unknown device name - Product Code 79F
|
| Product | Surgical Mesh |
|---|
| Code Information |
lot number 547628 |
Recalling Firm/
Manufacturer |
Synovis Surgical Inovation Div. of
2575 University Ave.
St. Paul MN 55114-1024
|
Manufacturer Reason
for Recall | A gap in the exterior seal may lead to sterility concerns with the interior pouch. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent to each consignee. |
|---|
| Quantity in Commerce | 28 devices |
|---|
| Distribution | Product shipped nationwide, no foreign consignees |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = 79F
|
|---|
