SCORPIO U-Dome Patella Knee Implant Recalled Due to Material Degradation Risk
Howmedica Osteonics has recalled certain SCORPIO U-Dome Patella knee implants due to potential material oxidation in units manufactured with raw material over 5 years old. The oxidation may affect the implant's 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 medical device recall for an orthopedic implant where material degradation presents a risk of harm. However, no injuries or illnesses have been reported in the source text, and the hazard is described as a 'potential' concern, making it theoretical. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High (3) severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO U-Dome Patella, a knee replacement implant (Part Number 73-3308). This product was manufactured using UHMWPE raw material that was more than 5 years of age.
The affected product has the potential for elevated levels of oxidation in the UHMWPE material. Oxidation within the material can impact its material properties.
One unit has been distributed in the United States, with 146 additional units distributed internationally. The affected lot numbers are: 2H58, 2J0W, 8H52, 64MJ, X0H9, and 70E9. International distribution includes Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308
- 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 (6)
- GTIN: 07613327033878 Lot Numbers: 2H58
- 2J0W
- 8H52
- 64MJ
- X0H9
- 70E9
Distribution
Distributed nationwide across the United States.
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