Z-0866-2021Class II

OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) -

Name: Z-0866-2021 OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) -
Creator: Skeletal Kinetics, Llc
Published: 2019-06-06
License: https://open.fda.gov/license/

Skeletal Kinetics, LLC / initiated 2019-06-06 / Terminated / root cause: labeling and UDI

FDA source

Skeletal Kinetics, Llc began a recall of OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler... on 2019-06-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0866-2021
Classification: Class II
Status: Terminated
Initiated: 2019-06-06
Posted: 2021-01-15
Terminated: 2024-09-18
Recalling firm: Skeletal Kinetics, LLC
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.
Product code: GXP Methyl Methacrylate For Cranioplasty
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On June 7, 2019, customers were notified by letter sent by FedEx that Skeletal Kinetics LLC (Skeletal Kinetics) is voluntarily recalling certain OsteoVation, Inject Bone Void Filler kits distributed by OsteoMed LLC.The recall was initiated to correct a discrepancy between the Mixing Instruction Card and the Instructions for Use. The letter notes that Skeletal Kinetics has not received any customer complaints or reports of injury to the patient or end user. Customers are requested to: (1) review this letter in full, review current inventory, and complete and return the Acknowledgement and Receipt Form via email or the enclosed pre-paid envelope; and (2) return unused inventory via Federal Express with reference to Return Material Authorization FER 3003890476-6/6/19-001-R or by pickup by the sales representative indicated on the Acknowledgement and Receipt Form. Customers with questions are instructed to contact Mr. Randy Mosley, Director of QA, Skeletal Kinetics LLC by telephone at 972 677 4789 Monday-Friday, 8 AM 5 PM CDT.
Quantity in commerce: 2 units
Distribution: U.S. Nationwide distribution including in the states of TX, NY, FL and AZ.
Product codes and lots: OsteoVation, Inject, 5cc (part number 390-2005, manufacturing lot number 1129957, label no. 12464) . UDI: (01) 0 0813845 02005 4 (17) 210401 (10) 1129957

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0866-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15
Z-0867-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15

Product code GXP

K051784Class IIOsteovation Cmf Bone Void FillerSkeletal Kinetics, LLC / cleared 2005-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)