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Novo Surgical Inc.
NOVO SURGICAL, INC. · Model N93815-31 · UDI-DI 00842331169878
GFJ
Prescription
3
510(k) clearances
17
Adverse events
2
Recalls
175
Facilities
Description
zenith hajek bone mallet, 6 1/2 oz., solid, 1" diameter head, 8 1/4" (21.0 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.