SCORPIO U-DOME PATELLA Knee Implants Affected by Material Oxidation Risk
Certain SCORPIO U-DOME PATELLA knee replacement devices may experience material degradation due to aged raw material. The manufacturer is recalling affected units because material oxidation could compromise device durability and performance.
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: FDA Class II recall for potential material degradation in an implanted medical device. The source identifies oxidation as having potential to impact device properties, but no adverse events have been reported, placing this at the High severity level as a risk-of-harm product without yet-reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling certain SCORPIO U-DOME PATELLA knee replacement devices (Part Number 73-3708) due to potential material degradation. The recall affects approximately 149 units distributed in the United States and 424 units distributed overseas to multiple countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, Spain, and the Netherlands.
The affected devices were manufactured using ultra-high-molecular-weight polyethylene (UHMWPE) raw material that is over 5 years of age. Such aged material has the potential to develop elevated levels of oxidation, which can negatively impact the material's properties and potentially affect device durability.
No injuries or adverse events related to this issue have been reported to date. Patients with affected devices should contact their healthcare provider for guidance. Healthcare providers are encouraged to report any adverse events to the FDA.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Knee Implant
- 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 (20)
- GTIN: 07613327033892 Lot Numbers: RDWN
- 4W3T
- V768
- VJ05
- TWT6
- ADK0
- 855
- D6D9
- TXL1
- 53RN
- KR24
- M3T4
- VE90
- EKK2
- 36L1
- NH6E
- 8PWK
- R9A4
- NWXA
- D47L
Distribution
Distributed nationwide across the United States.
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