FDA-Device2021-01-27Class II
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Skeletal Kinetics, Llc
Hazard
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Sold states
U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Affected count
49 units
Manufactured in
3885 Arapaho Rd, N/A, Addison, TX, United States
Products
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0867-2021Don'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