FDA-Device2019-06-05Class II
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Exactech, Inc.
Hazard
The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
Sold states
OK, VA, FL
Affected count
3 units
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2019Don't want to check this manually?
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