MEDARTIS AG
4 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (4)
Registered facilities (2)
- Medartis Inc. FEI 3009540749 · IN
- MEDARTIS AG FEI 3003236702 · CH
Recalls & enforcement
- Class IIOngoing2026-04-24The cannulation of the CCS screw is not centered.
- Class IIOngoing2026-01-09Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
- Class IIOngoing2024-04-12Screw is 16mm long instead of 22mm long.
- Class IITerminated2014-10-01A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “MEDARTIS AG — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9033581-medartis-ag/
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