Mallet, Surgical, General & Plastic Surgery

FDA product code GFJ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery

3510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K85178929-200 to 29-230 Various Bone Mallets(Wihiger, DoyGFJ · Traditional Artiberia06/20/1985SE
K844017Microtens 7757 T.E.N.S. StimulatorGFJ · Traditional Rabar, Inc.11/30/1984SE
K822204ENT MalletsGFJ · Traditional Kelleher Corp.09/17/1982SE

Recalls

RecallProductFirmInitiated
Z-0696-2020 Class IIsmith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet…There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the… Smith & Nephew, Inc.11/11/2019Terminated
Z-1834-2017 Class IISoft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical… Signal Medical Corporation02/20/2017Terminated