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Smith & Nephew, Inc. · Model 72201730 · UDI-DI 03596010610331

FEI Prescription
2
510(k) clearances
19
Adverse events
2
Recalls
35
Facilities

Description

COUPLER HD 16:9 26.5MM

Recalls

DateFirmReason
2016-10-04MedtronicProduct sterility is compromised due to breach of the sterile barrier
2016-10-04MedtronicProduct sterility is compromised due to breach of the sterile barrier

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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.