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Novo Surgical Inc.
NOVO SURGICAL, INC. · Model OB6361-13 · UDI-DI 00842331162312
KOH
Prescription
10
510(k) clearances
97
Adverse events
2
Recalls
83
Facilities
Description
doyen tumor screw, small pattern, 20.0 mm diameter, 6 3/4" (17.0 cm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-15 | Boston Scientific Corporation | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection |
| 2003-02-20 | Portex, Inc | May have incorrectly printed graduation markings along the tube shaft. |
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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.