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Teeth Screw Driver

ENTER MEDICAL CORPORATION · Model PN-2002 · UDI-DI 04719872108795

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510(k) clearances

Adverse events

Recalls

Facilities

Description

A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention.

Recalls

Date	Firm	Reason
2010-06-25	Biomet Microfixation, Inc.	Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5 pack, lot # 233270. This product is being recalled due to the possibility

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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.