medical Class II Updated 2021-01-27

Skeletal Kinetics, Llc recalls OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2

Recalled Product

OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - 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, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957
View official government recall

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