Class II
Medical Device Recall: Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Synthes (USA) Products LLC · January 24, 2024
Reason for Recall
Products not sterilized, sterility cannot be confirmed
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.
States Affected
NATIONWIDE
Quantity Affected
30 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1242-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.