OSUNG MND

OSUNG MND Co., Ltd. · Model ST1 · UDI-DI 08800075610973

510(k) clearances

Adverse events

Recalls

Facilities

Description

A small container designed as a bone-harvesting device (bone trap) to collect autologous bone fragments, e.g., when drilling in the jawbone during a dental implant surgical procedure. It functions as a filter that traps the bone particles and is typically placed in a suction tube line between the site of operation and the suction unit. The harvested bone particles may be saved for future use. This is a single-use device.

Recalls

Date	Firm	Reason
2020-12-07	Oto Med Inc	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
2020-12-07	Oto Med Inc	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
2020-12-07	Oto Med Inc	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

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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.