Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Recall Initiated
- July 15, 2025
- Posted
- August 11, 2025
- Recall Number
- Z-2288-2025
- Quantity
- 46 units
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.
Lot / Code Info
Item Number: 198-828/04. UDI-DI: 04026575193783. Serial Numbers: 211117/0069, 211117/0070, 211117/0071, 211117/0073, 211117/0078, 220204/0613, 220204/0614, 220204/0615, 220204/0616, 220204/0617, 220204/0618, 220204/0619, 220204/0620, 220204/0621, 220204/0622, 220204/0623, 220204/0624, 220204/0627, 220304/0074, 220304/0075, 220304/0076, 220304/0077, 220304/0078, 220304/0080, 220304/0081, 220304/0082, 220304/0083, 220517/0052, 220517/0069, 220517/0070, 220517/0071, 220517/0072, 220517/0073, 220517/0074, 220517/0076, 220517/0078, 220517/0079, 220517/0080, 220517/0081, 220517/0085, 220517/0088, 220517/0089, 220517/0090, 221011/0093, 240415/3890, 240415/3896.
Root Cause
Under Investigation by firm
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.