| Date Initiated by Firm | May 05, 2004 |
|---|
| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 15, 2006 |
| Recall Number | Z-0958-04 |
|---|
| Recall Event ID |
28998 |
| 510(K)Number | K013860 |
|---|
| Product Classification |
Staple, Implantable - Product Code GDW
|
| Product | Auto Suture TA 30 Reloadable Staplers, Single Patient Use
Ref TA30V3S, V3 (2.5mm) DST Series |
|---|
| Code Information |
LOT# P2J507 P2J972 P2K1034 P2K616 P2L334 P2L335 P2L607 P2M694 P2M695 P3A83 P3B307 P3D245 P3D564 P3E236 P3E309 P3F683 P3G300 P3G855 P3H21 P3J263 P3J408 P3J42 P3K13 P3L1011 P3L1012 P3L1133 P3L1134 P3L13 P3L237 P3L447 P3L628 P3L728 P3M558 P3M668 P4A636 P4B176 U2H11 U2H17 U2J01 U2J02 |
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 |
|---|
FDA Determined
Cause 2 | Other |
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| 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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