PlainRecordsFDA · Medical device recall
Proximate Linear Cutter with Safety Lock-Out… and 1 more product
- Date posted by the FDA
- July 8, 2003
- Status
- Terminated
- Filed by
- Ethicon Endo-Surgery
- Reason
- The Linear Cutters may have unsharpened knife blades that may prevent the device from operating properly.
- Distribution pattern
- The product was shipped to hospitals and distributors located nationwide.
2 products in this recall
Proximate Linear Cutter with Safety Lock-Out…
- 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.
- Quantity
- 8 units
- Codes and lots
- Lot Number: T4W32E, Exp 2008-03.
- Recall started
- May 21, 2003
- Device type
- Instrument, Manual, Surgical, General Use
- Root cause (FDA)
- Other
- What the company told customers
- The firm contacted their customers by FedEx on 5/21/2003.
- Recall number
- Z-0985-03
Proximate Linear Cutter with Safety Lock-Out…
- 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.
- Quantity
- 72 units
- Codes and lots
- Lot Number: T4W128, Exp 2008-03.
- Recall started
- May 21, 2003
- Device type
- Instrument, Manual, Surgical, General Use
- Root cause (FDA)
- Other
- What the company told customers
- The firm contacted their customers by FedEx on 5/21/2003.
- Recall number
- Z-0986-03
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0985-03, Z-0986-03. The agency record governs; check it and the company before acting.