Home / Recalls / Medical Devices
Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231
Recalled March 13, 2024 · FDA recall Z-1242-2024 · Synthes (USA) Products
Hazard
Products not sterilized, sterility cannot be confirmed · FDA Class II
Units
30 units
Sold at
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.
Description
Products not sterilized, sterility cannot be confirmed
Product
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →