Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
FDA Recall #Z-2289-2025 — Class II — July 15, 2025
Product Description
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
Recalling Firm
Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
17 units
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.
Code Information
Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168, C424053
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.