Device product
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Z-1242-2024
Product summary
- Event
- Event 93924
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-1242-2024
Official wording
Reason: Products not sterilized, sterility cannot be confirmed
Code information: UDI: 07611819318489 Lot Number: 427P153
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Derived failure modes
-
Sterility assurance
sterility cannot be confirmed