• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Proximate Linear Cutter

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 3 Device Recall Proximate Linear Cutter see related information
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/
Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242
For Additional Information Contact
Manufacturer Reason
for Recall
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
FDA Determined
Cause 2
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.