Facility

Medartis Inc.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009540749
Establishment type	Repack or Relabel Medical Device
Location	1195 Polk Drive Warsaw, IN, US 46582
Registration status	Active · expires 2026
Parent company	MEDARTIS AG (owner-operator 9033581)
Brand names	APTUS Elbow Dorsal Olecranon Plates

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (2)

Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
Plate, Fixation, Bone
Product code HRS (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

Recalls & enforcement

Class IIOngoing2026-04-24
The cannulation of the CCS screw is not centered.
Class IIOngoing2026-01-09
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Class IIOngoing2024-04-12
Screw is 16mm long instead of 22mm long.
Class IITerminated2014-10-01
A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.

FDA inspections (2)

VAI2026-06-03
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2021-09-03
Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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

Cite this record

RegWarden. “Medartis Inc. (FEI 3009540749) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009540749-medartis-inc/

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