FDA Enforcement
Class II
Ongoing
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Recall: Z-1242-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1242-2024
- Event ID
- 93924
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Synthes (USA) Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 13, 2024
- Initiation Date
- January 24, 2024
- Classification Date
- March 1, 2024
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States
Description
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Reason
Products not sterilized, sterility cannot be confirmed
Code Info
UDI: 07611819318489 Lot Number: 427P153
Distribution
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.
Quantity
30 units