FDA Enforcement
Class II
Ongoing
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
Recall: Z-0884-2024
·
Reported February 7, 2024
Enforcement
- Recall Number
- Z-0884-2024
- Event ID
- 93687
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 7, 2024
- Initiation Date
- December 1, 2023
- Classification Date
- January 31, 2024
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2006, United States
Description
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
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 Info
GTIN: 07613154020638 Lot Numbers: 42968601
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.
Quantity
5 units US