FDAHealthJuly 15, 2025

Waldemar Link GmbH & Co. KG (Mfg Site) — Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.

⚠️ Inconsistent size terminology and color coding used on labeling

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: July 15, 2025

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.

What's affected?

Product: Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Brand: Waldemar Link GmbH & Co. KG (Mfg Site)
Lot code: Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168, C424053

Additional details

Item Number: 175-928/15. UDI-DI: 04026575150700. Serial Numbers: C126168, C424053

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 17 units.

View original FDA notice →

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