Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Pending LLM rewrite. Source: FDA_DEVICE Z-2288-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Inconsistent size terminology and color coding used on labeling
The recalled product
- Product
- Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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