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Hensler Bone Collector

Hensler Surgical · Model HBC · UDI-DI 00853755004010

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Hensler Bone Collector device is a brush/bristle cap with a screw on container. The bristles can sweep bone fragments from surgical tools into the container for use in augmentation procedures as a natural unadulterated bone filling material. The device is non-powered, single-use and disposable. The Hensler Bone Collector device is intended for sterile, single-use to manually collect autogeneous bone particles that are utilized in augmentation procedures. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians.

Recalls

Date	Firm	Reason
2013-11-04	Medline Industries Inc	There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.

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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.