| Date Initiated by Firm | May 05, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 15, 2006 |
| Recall Number | Z-0959-04 |
|---|
| Recall Event ID |
28998 |
| 510(K)Number | K013860 |
|---|
| Product Classification |
Staple, Implantable - Product Code GDW
|
| Product | Auto SutureTA 30 Reloadable Stapler,Single Patient Use,3.5mm DST Series
Ref: TA3035S |
|---|
| Code Information |
LOT# P2J505 P2J971 P2K1031 P2K813 P2L332 P2L603 P2L604 P2M227 P2M228 P2M235 P2M82 P3A1151 P3A323 P3A443 P3A908 P3B336 P3B607 P3C710 P3C802 P3D563 P3D944 P3E233 P3E294 P3G08 P3G09 P3G417 P3G621 P3G769 P3H288 P3H638 P3J41 P3J456 P3K05 P3K06 P3K07 P3K08 P3L1007 P3L1008 P3L11 P3L1129 P3L1130 P3L12 P3L243 P3L42 P3L425 P3L440 P3L441 P3M368 P3M369 P4A634 P4A881 U2H02 U2H08 |
Recalling Firm/
Manufacturer |
United States Surgical
195 Mcdermott Rd
North Haven CT 06473-3665
|
| For Additional Information Contact | Garry Raymond
203-492-8165 |
|---|
Manufacturer Reason
for Recall | Stapler may clamp without the staples being fired into the tissue |
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FDA Determined
Cause 2 | Other |
|---|
| Action | United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS. |
|---|
| Distribution | Nationwide |
|---|
| 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 = GDW
|
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