FDA recall Z-0488-2026

Product

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Reason for recall

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

Distribution

US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,

Key facts

Status

Ongoing

Initiation date

2025-10-13

Report date

2025-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ventura, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2026