Recall Z-0867-2021— Skeletal Kinetics, Llc

Name: FDA recall Z-0867-2021
Creator: U.S. Food and Drug Administration
Published: 2019-06-06

Class II · Terminated

Class II FDA medical device recall by Skeletal Kinetics, Llc, initiated 2019-06-06, terminated 2024-09-18. It names one FDA 510(k) clearance: K051784. 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: 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..

Recalling firm: Skeletal Kinetics, Llc
Classification: Class II
Status: Terminated
Initiated: 2019-06-06
Terminated: 2024-09-18
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K051784 — OSTEOVATION CMF BONE VOID FILLERSkeletal Kinetics, LLC·cleared 2005-07-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.