FDA Device Intelligence
HomeSynthes GmbH › NA

NA

Synthes GmbH · Model 04.641.119 · UDI-DI 10705034750545

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

Description

TI DISTAL EXTENSION SIZE 9/220MM 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.