FDA recall Z-0867-2021

Skeletal Kinetics, Llc · Class II · device

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.

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-06-06
Report date
2021-01-27
Termination date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Addison, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0867-2021