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Circular Stapler Head Sizer Set
TOOLS FOR SURGERY, LLC · Model HSS-10 · UDI-DI 00860002701394
10
510(k) clearances
37
Adverse events
6
Recalls
114
Facilities
Description
Circular Stapler Head Sizer Set includes (1) 25 mm, (1) 29 mm, and (1) 33 mm reusable head sizers that are used to assist in choosing surgical stapler size.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2020-04-01 | Aesculap Implant Systems LLC | Endoscopic graspers may become separated at the weld from handle to the shaft of the device. |
| 2019-04-10 | Uromedica Inc. | Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT i |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
| 2017-05-01 | Cook Inc. | COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti |
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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.