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Swann Morton Ltd.
SWANN-MORTON LIMITED · Model STITCH CUTTER STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD · UDI-DI 05033955036263
10
510(k) clearances
607
Adverse events
6
Recalls
255
Facilities
Description
A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2010-06-04 | Maquet Cardiovascular | Pouch integrity may be compromised, resulting in loss of sterility. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
| 2008-04-24 | Ethicon Endo-Surgery Inc | The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.