Date Initiated by Firm |
May 21, 2003 |
Date Posted |
July 08, 2003 |
Recall Status1 |
Terminated 3 on December 10, 2003 |
Recall Number |
Z-0985-03 |
Recall Event ID |
26386 |
510(K)Number |
k020779
|
Product Classification |
Instrument, Manual, Surgical, General Use - Product Code MDM
|
Product |
Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife, Product No. TCT10, staple size: 3 mm x 4.5 mm. |
Code Information |
Lot Number: T4W32E, Exp 2008-03. |
Recalling Firm/ Manufacturer |
Ethicon Endo-Surgery 4545 Creek Rd Cincinnati OH 45242
|
For Additional Information Contact |
513-337-8205
|
Manufacturer Reason for Recall |
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
|
FDA Determined Cause 2 |
Other |
Action |
The firm contacted their customers by FedEx on 5/21/2003. |
Quantity in Commerce |
8 units |
Distribution |
The product was shipped to hospitals and distributors located 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 = MDM and Original Applicant = ETHICON ENDO-SURGERY, INC.
|