Date Initiated by Firm | May 05, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on November 15, 2006 |
Recall Number | Z-0962-04 |
Recall Event ID |
28998 |
510(K)Number | K013860 |
Product Classification |
Staple, Implantable - Product Code GDW
|
Product | Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 4.8mm DST Series
Ref: TA4548S |
Code Information |
LOT# P2H776 P2J263 P2J607 P2J792 P2J793 P2L647 P2L648 P2M243 P2M244 P2M552 P3A118 P3A413 P3A909 P3B341 P3B342 P3B343 P3B344 P3B611 P3B848 P3C239 P3C241 P3C437 P3C439 P3C588 P3E18 P3E238 P3E301 P3E524 P3E525 P3E647 P3F115 P3F225 P3F352 P3F446 P3H252 P3H280 P3H404 P3H431 P3H432 P3H640 P3H641 P3J45 P3J46 P3J47 P3J712 P3J713 P3K20 P3L1004 P3L1005 P3L1006 P3L1138 P3L1139 P3L238 P3L239 P3L450 P3L630 P3L631 LOT# P3L729 P3M464 P4A126 P4A128 P4A336 P4A337 P4A338 P4A544 P4A549 P4A884 P4A885 P4B242 P4B587 P4B710 U2E10 U2E12 U2F02 U2F16 U2F20 U2G04 U2G06 U2G09 |
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 |
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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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510(K) Database | 510(K)s with Product Code = GDW
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