Skeletal Kinetics, Llc: Medical Device Recall in 2021 - (Recall #: Z-0867-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 6, 2019

Date Posted: January 27, 2021

Recall Number: Z-0867-2021

Event ID: 85133

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.

Status: Terminated

Product Quantity: 49 units

Code Information:

OsteoVation, Inject, 10cc (part number 390-2010, manufacturing lot 1130303, label no 12464). UDI (2): (01) 0 0813845 02006 1 (17) 210501 (10) 1130303

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated