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OSUNG MND

OSUNG MND Co., Ltd. · Model ML20 · UDI-DI 08800075610331

HXL

510(k) clearances

Adverse events

Recalls

202

Facilities

Description

A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Recalls

Date	Firm	Reason
2021-07-21	Implant Resource Inc	Potential 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.