Home › KOROS U.S.A., INC. › Long Cervical Micro-Bayonet Curette Set

Long Cervical Micro-Bayonet Curette Set

KOROS U.S.A., INC. · Model 7418-00L · UDI-DI 10840199543752

FZS Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

219

Facilities

Description

Aescalap Type Long Cervical Micro-Bayonet Curette Set Consists of the Following: 1 x 7418-10L, 1 x 7418-20L, 1 x 7418-30L, 1 x 7418-40L, 1 x 7418-80L, 1 x 7418-12L, 1 x 7418-22L, 1 x 7418-32L, 1 x 7418-42L, 1 x 7418-82L, 1 x 7418-14L, 1 x 7418-24L, 1 x 7418-34L, 1 x 7418-44L, 1 x 7418-84L, 1 x 7418-16L, 1 x 7418-26L, 1 x 7418-36L, 1 x 7418-46L, 1 x 7418-91L, 1 x 7418-92L, 1 x 7418-93 & 1 x 7418-95

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2013-11-05	Zimmer, Inc.	Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged pr
2011-07-15	X Spine Systems Inc	The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque i

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.