FDA recall Z-1267-2023

Product

Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

Reason for recall

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

Key facts

Status

Ongoing

Initiation date

2023-02-15

Report date

2023-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2023