Date Initiated by Firm | May 05, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on November 15, 2006 |
Recall Number | Z-0966-04 |
Recall Event ID |
28998 |
510(K)Number | K013860 |
Product Classification |
Staple, Implantable - Product Code GDW
|
Product | Auto SutureTA 90 Reloadable Stapler,Single Patient Use, 4.8mm DST Series
Ref: TA9048S |
Code Information |
LOT# P2H677 P2H678 P2J787 P2J788 P2L645 P2L646 P2L650 P2M226 P2M693 P3A652 P3B308 P3B613 P3C426 P3C432 P3C819 P3D953 P3E649 P3F116 P3F841 P3G16 P3G17 P3H281 P3H282 P3H447 P3H448 P3K27 P3K362 P3L1014 P3L1015 P3L1142 P3L231 P3L232 P3L45 P3L464 P3L465 P3L466 P3L731 P4A546 P4A643 P4A891 U2G15 |
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.
|
510(K) Database | 510(K)s with Product Code = GDW
|