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Synthes GmbH · Model 497.109 · UDI-DI 10705034787367

MDI Prescription
1
510(k) clearances
1,052
Adverse events (15 deaths)
1
Recalls
5
Facilities

Description

TI RIB SLEEVE-SIZE 10 220MM RADIUS

Recalls

DateFirmReason
2015-07-29Synthes (USA) Products LLCThe last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the

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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.