Class 3 Device Recall Proximate Linear Cutter

• Date Initiated by Firm: May 21, 2003
• Date Posted: July 08, 2003
• Recall Status: Terminated on December 10, 2003
• Recall Number: Z-0986-03
• 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. #TLC10, staple size: 3 mm x 3.85 mm.
• Code Information: Lot Number: T4W128, 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: Other
• Action: The firm contacted their customers by FedEx on 5/21/2003.
• Quantity in Commerce: 72 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