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Comfort Plus Curette Set

KOROS U.S.A., INC. · Model 7561-00 · UDI-DI 10840199544094

FZS Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

219

Facilities

Description

Comfort Plus Curette Set Consists of the Following: 1 x 7561-07, 1 x 7561-09, 1 x 7561-11, 1 x 7561-13, 1 x 7561-15, 1 x 7563-07, 1 x 7563-09, 1 x 7563-11, 1 x 7565-07, 1 x 7565-09 & 1 x 7520-30

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

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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.