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Spinal Exploration Probe Set

KOROS U.S.A., INC. · Model 7335-50 · UDI-DI 10840199516930

FZS KAK Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

219

Facilities

Description

Spinal Exploration Probe Set, Consists of the Following: 1 x 7335-10 Spinal Exploration Probe 2 x 12mm, 1 x 7335-15 Spinal Exploration Probe 2 x 18mm, 1 x 7335-20 Spinal Exploration Probe 45 degree x 20mm, 1 x 7335-25 Spinal Exploration Probe 3.2 x 12mm & 1 x 7335-30 Spinal Exploration Probe 3.2 x 18mm

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.