Z-0985-03

Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife...

Name: Z-0985-03 Proximate Linear Cutter with Safety Lock-Out, Reloadable, contains 100 titanium staples with integral knife...
Creator: Ethicon Endo-Surgery
Published: 2003-05-21
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2003-05-21 / Terminated

FDA source

Ethicon Endo-Surgery began a recall of 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 on 2003-05-21. The reason FDA records is "The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0985-03
Status: Terminated
Initiated: 2003-05-21
Posted: 2003-07-08
Terminated: 2003-12-10
Recalling firm: Ethicon Endo-Surgery Inc
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.
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
FDA root cause: 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.
Product codes and lots: Lot Number: T4W32E, Exp 2008-03.

Product code MDM

K020779Class IIProximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc. / cleared 2002-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)