| Date Initiated by Firm | May 05, 2004 |
|---|
| Date Posted | July 20, 2004 |
|---|
| Recall Status1 |
Terminated 3 on November 15, 2006 |
| Recall Number | Z-0965-04 |
|---|
| Recall Event ID |
28998 |
| Product Classification |
Staple, Implantable - Product Code GDW
|
| Product | Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 3.5mm DST Series
Ref: TA9035S |
|---|
| Code Information |
LOT# P2H679 P2J642 P2K1113 P2K534 P2K66 P2L609 P2L610 P2L611 P2L649 P2M692 P3A650 P3C425 P3C800 P3E304 P3F686 P3G15 P3G414 P3J249 P3J250 P3J256 P3L1013 P3L1141 P3L242 P3L44 P3L462 P3L639 P4A547 P4A642 P4A890 P4B727 U2G21 |
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 |
|---|
| 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.
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