RegWardenFDA facility compliance records
Recall

Class II — Medartis, Inc.

Recalling firmMEDARTIS AG
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonA recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.
ProductAPTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.
Quantity44
DistributionUS Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.
Initiated2014-10-01
Classified2014-10-30
Terminated2015-08-06
Recall numberZ-0150-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Medartis, Inc. (Z-0150-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69433/

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