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COGNiTiON™ Staple System

ORTHO SOLUTIONS HOLDINGS LIMITED · Model OS380903-NS · UDI-DI 05055662969757

HXJ Prescription
6
510(k) clearances
1
Adverse events
2
Recalls
44
Facilities

Description

INSERTER 2 LEG X 20MM

Recalls

DateFirmReason
2006-05-17Xiros PlcThe impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination
2006-05-17Xiros PlcThe impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination

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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.