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EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm

Micromar Indústria e Comércio Ltda · Model DM0008FAA · UDI-DI 07898959543166

HBF Prescription

510(k) clearances

2,719

Adverse events (2 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2025-09-26	Integra LifeSciences Corp. (NeuroSciences)	Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
2025-09-26	Integra LifeSciences Corp. (NeuroSciences)	Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
2025-04-11	Integra LifeSciences Corp. (NeuroSciences)	Inadequate weld that can potentially cause the product to disassemble.
2025-04-11	Integra LifeSciences Corp. (NeuroSciences)	Inadequate weld that can potentially cause the product to disassemble.
2020-10-16	Stryker Instruments Div. of Stryker Corporation	Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
2011-07-08	Biomet Microfixation, Inc.	Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When

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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.