Class II

Medical Device Recall: Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.

Waldemar Link GmbH & Co. KG (Mfg Site) · July 15, 2025

Reason for Recall

Inconsistent size terminology and color coding used on labeling

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, Peru, Slovenia, and Uruguay.

States Affected

NATIONWIDE

Quantity Affected

46 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2288-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.