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Stainless Steel Head for Mallet

SONTEC INSTRUMENTS, INC. · Model 1100-462SH · UDI-DI 00192896108561

HXL Prescription
3
510(k) clearances
75
Adverse events
1
Recalls
202
Facilities

Description

Stainless Steel Head for Mallet 1.0 Inch 1100-462S

Recalls

DateFirmReason
2021-07-21Implant Resource IncPotential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected

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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.