Skeletal Kinetics, Llc recalls OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The produ…

Recall date

June 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0867-2021

FDA classification

Class II

Brand / firm

Skeletal Kinetics, Llc

Sold / distributed

U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.