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MicroFrance®

INTEGRA MICROFRANCE · Model CP300 · UDI-DI 10381780098126

GFJ Prescription
3
510(k) clearances
17
Adverse events
2
Recalls
175
Facilities

Description

MALLET CP300 180MM 230 GRAM

Recalls

DateFirmReason
2019-11-11Smith & 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
2017-02-20Signal Medical CorporationPotential 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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Data 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.