SCORPIO U-DOME PATELLA -Intended for knee replacement recall
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Why was SCORPIO U-DOME PATELLA -Intended for knee replacement recalled?
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 07613327033908 Lot Numbers: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, R608
- Product
- SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 118 units US; 212 units OUS
- Distribution
- Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)