Knee Replacement Component Recalled for Potential Material Degradation
Howmedica Osteonics Corp. recalls SCORPIO U-DOME PATELLA knee replacement components due to potential oxidation in raw materials over 5 years old, which could affect material properties.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a knee replacement component with potential material degradation (oxidation) affecting material properties. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, consistent with a High severity score per the rubric.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO U-DOME PATELLA knee replacement components (Part Number 73-3110) manufactured with UHMWPE raw material that is over 5 years of age.
The recalled components may have elevated levels of oxidation within the UHMWPE material. Oxidation can impact the material properties of the component, potentially affecting its performance.
A total of 107 units were distributed in the United States and 176 units were distributed internationally to Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, Venlo (Netherlands), Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. The affected lot numbers are: XEA7, 8P83, 690Y, MRM3, 67D4, 4902, YNP7, 3AYN, AYHM, W3MD, 76KN, K4P9, 792H, 43T8, and MW40.
Patients and physicians should contact Howmedica Osteonics Corp. to determine if their knee replacement component is affected by this recall.
The recalled product
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
- Manufacturer
- Howmedica Osteonics Corp.
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 (15)
- GTIN: 07613327033861 Lot Numbers: XEA7
- 8P83
- 690Y
- MRM3
- 67D4
- 4902
- YNP7
- 3AYN
- AYHM
- W3MD
- 76KN
- K4P9
- 792H
- 43T8
- MW40
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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