FDA Recalls SCORPIO U-DOME Knee Implants for Potential Material Oxidation
Howmedica is recalling SCORPIO U-DOME PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old due to potential elevated oxidation levels that could affect 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: FDA Class II recall of an orthopedic implant with potential for material property degradation. This qualifies as a risk-of-harm product where injury has not yet been reported, placing it in the High severity category per the rubric.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO U-DOME PATELLA knee replacement implant (Part Number 73-3508) manufactured with UHMWPE (ultra-high-molecular-weight polyethylene) raw material over 5 years of age.
UHMWPE material in the recalled units may have elevated oxidation levels. Oxidation within the material can impact its mechanical properties, which may affect the implant's performance and longevity.
The recall affects 137 units distributed within the United States and 326 units distributed internationally, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. Affected lot numbers include: EPXH, DYAE, XVK2, PVP9, LJ0K, 12R3, N8P6, T355, 8HDN, A3EV, 5LKW, R04Y, RKT1, D06K, 01JR, 3PA4, 0AYL, W424, 53T1, and Y7X2.
Patients who have received this implant should contact their healthcare provider to determine if they have one of the recalled units and whether any action is needed.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- material-oxidation
- implant-failure
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: 07613327033885 Lot Numbers: EPXH
- DYAE
- XVK2
- PVP9
- LJ0K
- 12R3
- N8P6
- T355
- 8HDN
- A3EV
- 5LKW
- R04Y
- RKT1
- D06K
- 01JR
- 3PA4
- 0AYL
- W424
- 53T1
- Y7X2
Distribution
Distributed nationwide across the United States.
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