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Comfort Plus Mallet
KOROS U.S.A., INC. · Model 7530-12 · UDI-DI 10840199528582
GFJ
Prescription
3
510(k) clearances
17
Adverse events
2
Recalls
176
Facilities
Description
Comfort Plus Small Bone Mallet 12cm, 18oz
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.