FDA-Device2024-03-13Class II
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Synthes (USA) Products LLC
Hazard
Products not sterilized, sterility cannot be confirmed
Sold states
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.
Affected count
30 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1242-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief