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U.S. Department of Health and Human Services

Class 3 Device Recall Proximate Linear Cutter

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  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/
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.
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