OSUNG MND

OSUNG MND Co., Ltd. · Model TNC100 · UDI-DI 08800075610294

510(k) clearances

Adverse events

Recalls

Facilities

Description

A strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in various designs: 1) a pliers-like design with elongated blades, or 2) twin angled blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles; that, when squeezed together, close the blades so that they cut entirely through the bone. Also known as bone shears, it is mainly used in orthopaedic surgical procedures and oral surgery. This is a reusable device.

Recalls

Date	Firm	Reason
2018-03-28	Ace Surgical Supply Co., Inc.	The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.

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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.