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Novo Surgical Inc.
NOVO SURGICAL, INC. · Model N93813-24 · UDI-DI 00842331165122
GFJ
Prescription
3
510(k) clearances
17
Adverse events
2
Recalls
176
Facilities
Description
zenith mallet, small, lead filled head, 5 oz., 3/4" diameter head, 6 1/2" (16.5 cm)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-11 | Smith & Nephew, Inc. | There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure |
| 2017-02-20 | Signal Medical Corporation | Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip mus |
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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.