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Consensus Knee System

Shalby Advanced Technologies, Inc. · Model 2800-0-1250 · UDI-DI 00840286854085

FZO Prescription
2
510(k) clearances
318
Adverse events
1
Recalls
244
Facilities

Description

Trochlear Chisel/Step Punch

Recalls

DateFirmReason
2015-06-24Synthes (USA) Products LLCIt was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.

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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.