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ASSI

ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION · Model ASSI.FOAL266 · UDI-DI 00841645131908

FCW

510(k) clearances

2,959

Adverse events (1 deaths)

Recalls

Facilities

Description

Adapter for Fiber Optic Cable for Cuda Light Source

Recalls

Date	Firm	Reason
2023-03-02	Stryker Corporation	Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
2011-10-14	Integra LifeSciences Corp.	A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-10-14	Integra LifeSciences Corp.	A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-10-14	Integra LifeSciences Corp.	A loose screw may result in shifting of components and improper function of the turret or actuator assembly.
2011-03-07	Integra LifeSciences Corp.	Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

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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.