Z-1965-2009

iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010...

Name: Z-1965-2009 iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010...
Creator: Theken Spine LLC
Published: 2008-08-26
License: https://open.fda.gov/license/

Theken Companies LLC / initiated 2008-08-26 / Terminated / root cause: labeling and UDI

FDA source

Theken Spine LLC began a recall of iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04 on 2008-08-26. The reason FDA records is "Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04". 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-1965-2009
Status: Terminated
Initiated: 2008-08-26
Posted: 2009-09-03
Terminated: 2012-03-09
Recalling firm: Theken Companies LLC
Product: iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662.
Quantity in commerce: 22 units
Distribution: Nationwide Distribution -- TX.
Product codes and lots: Model Number: 50-05-0010; Lot Number: A07D02B.

Product code MQV

K040134Class IITherilink Bone Void FillerTherics, Inc. / cleared 2004-03-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)