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Anterior Long Curette Set

KOROS U.S.A., INC. · Model 7566-10 · UDI-DI 10840199544100

FZS Prescription
10
510(k) clearances
71
Adverse events (1 deaths)
3
Recalls
219
Facilities

Description

Anterior Long Curette Set Consists of the Following: 1 x 7566-07, 1 x 7566-09, 1 x 7566-11, 1 x 7566-13, 1 x 7566-15, 1 x 7566-17, 1 x 7566-19, 1 x 7566-21, 1 x 7566-27, 1 x 7566-29 & 1 x 7566-50

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2013-11-05Zimmer, 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
2011-07-15X Spine Systems IncThe 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.