FDA-Device2025-08-20Class II
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Hazard
Inconsistent size terminology and color coding used on labeling
Sold states
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.
Affected count
46 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2288-2025More Waldemar Link GmbH & Co. KG (Mfg Site) recalls
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