Z-0897-2024 Class II Ongoing
FDA device recall Z-0897-2024 was initiated by Howmedica Osteonics Corp. on December 1, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 118 units US; 212 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118 units US; 212 units OUS
Product Description
SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
Reason for Recall
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.
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.
Code Information
GTIN: 07613327033908 Lot Numbers: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, R608