Device product
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
Z-0896-2024
Product summary
- Event
- Event 93687
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 149 units US; 424 units OUS
- Official record key
device-enforcement:Z-0896-2024
Official wording
Reason: 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.
Code information: GTIN: 07613327033892 Lot Numbers: RDWN, 4W3T, V768, VJ05, TWT6, ADK0, 855, D6D9, TXL1, 53RN, KR24, M3T4, VE90, EKK2, 36L1, NH6E, 8PWK, R9A4, NWXA, D47L, 5JVL, D16P, E2LP, 927H, JR5N
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.