Atlas FDA

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

FDA device recall Z-2289-2025 · posted 2025-08-11 · Open, Classified

Recall details

Recalling firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Reason for recall
Inconsistent size terminology and color coding used on labeling
Action taken
Waldemar Link GmbH & Co. notified consignees of the recall via email on about 07/15/2025. Consignees were instructed to respond using the Distributor Reply form and arrange for the return of all affected product on hand.
Root cause
Under Investigation by firm
Status
Open, Classified
Product code
JDG
Quantity affected
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
Date initiated
2025-07-15
Date posted
2025-08-11
Location
Norderstedt, Germany

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