Knee replacement component recalled due to potential material oxidation
Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard involves potential material property degradation in a prosthetic component due to oxidation, which represents a risk of harm where injury has not yet been reported, warranting a High (Score 3) severity rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO U-DOME PATELLA knee replacement components (Part Number 73-3710). A total of 118 units were distributed in the United States, with an additional 212 units distributed to international markets.
The recall was initiated because UHMWPE raw material older than 5 years may have elevated oxidation levels. Oxidation within UHMWPE can compromise its material properties, which are essential for proper function of the knee prosthetic component.
The affected lot numbers are: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, and R608. The product was distributed nationwide within the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and other countries.
Patients and healthcare providers should contact Howmedica Osteonics Corp. or the FDA with questions regarding this recall or if they have concerns about affected implants.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- oxidation
- material-degradation
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 (12)
- GTIN: 07613327033908 Lot Numbers: RNT5
- 3YNP
- PEA1
- NNA5
- 5A2R
- 98AH
- T1JH
- 8D72
- E0VH
- 3PA0
- 05L4
- R608
Distribution
Distributed nationwide across the United States.
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