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Skeletal Kinetics, Llc recalls OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The produc
Recalled January 27, 2021 · FDA recall Z-0867-2021 · Skeletal Kinetics
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. · FDA Class II
Units
49 units
Sold at
U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Description
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.
Product
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.
Manufacturer(s)
Skeletal Kinetics, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →