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Replacement Blade Kit

KOROS U.S.A., INC. · Model 9100-50 · UDI-DI 10840199539052

HXZ Prescription
1
510(k) clearances
513
Adverse events
1
Recalls
246
Facilities

Description

Replacement Blade Kit w/ 1 Blade and 4 Screws for Item 9100-18

Recalls

DateFirmReason
2020-11-20Zimmer Biomet, Inc.Device has the potential for fracture during use.

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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.