FDA recall Z-1821-2024

Product

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.

Distribution

Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.

Key facts

Status

Ongoing

Initiation date

2024-04-12

Report date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2024