FDA Medical Device Recalls (openFDA)
Ethicon Endo-Surgery: 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.
- Recall number
- Z-0986-03
- Recalling firm
- Ethicon Endo-Surgery
- 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.
- Status
- Terminated
- Initiated
- 2003-05-21
- Posted
- 2003-07-08
- Terminated
- 2003-12-10
- Reason
- The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
- Root cause
- Other
- Action
- The firm contacted their customers by FedEx on 5/21/2003.
- Quantity
- 72 units
- Distribution
- The product was shipped to hospitals and distributors located nationwide.
- Lot, serial or model codes
- Lot Number: T4W128, Exp 2008-03.
- 510(k) numbers
- ["K020779"]
- PMA numbers
- not on file
- Product code
- MDM
- Firm FEI
- 1527736
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28