Z-2288-2025 Class II Ongoing
FDA device recall Z-2288-2025 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on July 15, 2025 and is designated Class II. Reason for recall: Inconsistent size terminology and color coding used on labeling The recall status is ongoing. Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- July 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Reason for Recall
Inconsistent size terminology and color coding used on labeling
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.
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.