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Lumbar Micro-Bayonet Curette Set

KOROS U.S.A., INC. · Model 7419-00 · UDI-DI 10840199543769

FZS Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

219

Facilities

Description

Lumbar Micro-Bayonet Curette Set Consists of the Following: 1 x 7419-10, 1 x 7419-12, 1 x 7419-20, 1 x 7419-21, 1 x 7419-22, 1 x 7419-30, 1 x 7419-31, 1 x 7419-32, 1 x 7419-40, 1 x 7419-41, 1 x 7419-42, 1 x 7419-50, 1 x 7419-51, 1 x 7419-52, 1 x 7419-60, 1 x 7419-61, 1 x 7419-71, 1 x 7419-72, 1 x 7419-73, 1 x 7419-74, 1 x 7419-80, 1 x 7419-82 & 2 x 7419-95

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

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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.