medical Class II Updated 2021-01-27

Skeletal Kinetics, Llc recalls OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-

Recalled 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: OsteoVation, Inject, 10cc (part number 390-2010, manufacturing lot 1130303, label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303
View official government recall

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