FDA-Device2024-03-13Class II
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
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-1242-2024More Synthes (USA) Products LLC recalls
- FDA-Device2026-04-08Synthes VOLT Locking Screw Tap recalled for incorrect thread due to packaging mix-up
- FDA-Device2026-04-08Synthes 2.4 VOLT Cortex Screw recalled for incorrect thread due to lot swap
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