Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2025 - (Recall #: Z-2288-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 15, 2025

Date Posted: August 20, 2025

Recall Number: Z-2288-2025

Event ID: 97275

Reason for Recall:

Inconsistent size terminology and color coding used on labeling

Status: Ongoing

Product Quantity: 46 units

Code Information:

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated