FDA recall Z-2289-2025

Product

Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

Reason for recall

Inconsistent size terminology and color coding used on labeling

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.

Key facts

Status

Ongoing

Initiation date

2025-07-15

Report date

2025-08-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2289-2025