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Recall Observatory FDA recall evidence

Device product

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

Z-2289-2025

July 15, 2025

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 97275
Status
Ongoing
Classification
Class II
Quantity
17 units
Official record key
device-enforcement:Z-2289-2025

Official wording

Reason: Inconsistent size terminology and color coding used on labeling

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inconsistent size terminology and color coding used on labeling