Medical device recalls Moderate risk

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

Recall date
July 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2289-2025
FDA classification
Class II
Brand / firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Sold / distributed
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.

Why it was recalled

Inconsistent size terminology and color coding used on labeling

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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