Hip Prosthesis Labeling Has Inconsistent Size Terminology and Color Coding
Waldemar Link is recalling 46 units of Prosthesis Head B due to inconsistent size terminology and color coding on labeling, which could lead to confusion during product selection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The labeling inconsistency on a size-specific medical device creates a risk-of-harm scenario with potential for patient injury during implantation. No injuries have been reported. FDA Class II classification with theoretical risk of harm where injury has not yet been reported meets the High (Level 3) criterion per the rubric.
Plain-English summary
Waldemar Link GmbH & Co. KG is recalling 46 units of Prosthesis Head B, 28 mm with 7 mm neck length (Item Number 198-828/04), due to inconsistent size terminology and color coding on the product labeling.
The labeling inconsistency could lead to confusion during prosthesis selection and surgical planning, potentially resulting in selection of an incorrect size for implantation.
The affected units were distributed worldwide. In the United States, distribution was reported in Arizona, California, Florida, Indiana, Kansas, Louisiana, and New Jersey. International distribution included Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
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)
- Hazard
- size-confusion
- color-coding-error
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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