| Date Initiated by Firm | August 01, 2016 |
|---|
| Create Date | October 26, 2016 |
|---|
| Recall Status1 |
Terminated 3 on February 16, 2018 |
| Recall Number | Z-0316-2017 |
|---|
| Recall Event ID |
75142 |
| 510(K)Number | K031286 |
|---|
| Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
|
| Product | Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture |
|---|
| Code Information |
Lot # 115441 Product Code C1046619 |
| FEI Number |
2916714
|
Recalling Firm/
Manufacturer |
Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
|
| For Additional Information Contact |
800-258-1946 |
|---|
Manufacturer Reason
for Recall | There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | An Urgent Medical Device Recall Notification Letter was mailed to customers on August 11, 2016 asking them to remove and return the affected product immediately. |
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| Quantity in Commerce | 180 units |
|---|
| Distribution | Distributed in Arizona |
|---|
| 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.
|
| 510(K) Database | 510(K)s with Product Code = GAM
|
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