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.
FDA Recall Z-0985-03 · Posted 2003-07-08
Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeMDM
Date Initiated2003-05-21
Date Terminated2003-12-10
Product Quantity8 units
Reason for Recall
The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
Firm Action
The firm contacted their customers by FedEx on 5/21/2003.
Root Cause
Other
Distribution Pattern
The product was shipped to hospitals and distributors located nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.