PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 22, 2024 Initiated: April 12, 2024 #Z-1821-2024

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.

Details

Recalling Firm
Medartis Inc.
Units Affected
110 units
Distribution
Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.. Recalled by Medartis Inc.. Units affected: 110 units.
Why was this product recalled?
Screw is 16mm long instead of 22mm long.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 22, 2024. Severity: Moderate. Recall number: Z-1821-2024.