Recall Z-1821-2024— Medartis Inc.

Name: FDA recall Z-1821-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-12

Class II · Ongoing

Class II FDA medical device recall by Medartis Inc., initiated 2024-04-12. It names one FDA 510(k) clearance: K091479. Product: APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.. Reason: Screw is 16mm long instead of 22mm long..

Recalling firm: Medartis Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K091479 — APTUS FOOT SYSTEMMedartis AG·cleared 2009-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Reason for recall

Screw is 16mm long instead of 22mm long.

Data sourced from openFDA. This site is unofficial and independent of the FDA.