Z-2375-2008

FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following...

Name: Z-2375-2008 FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following...
Creator: Theken Spine LLC
Published: 2008-07-11
License: https://open.fda.gov/license/

Theken Companies LLC / initiated 2008-07-11 / Terminated / root cause: labeling and UDI

FDA source

Theken Spine LLC began a recall of FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable... on 2008-07-11. The reason FDA records is "The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06". 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-2375-2008
Status: Terminated
Initiated: 2008-07-11
Posted: 2008-09-18
Terminated: 2011-09-20
Recalling firm: Theken Companies LLC
Product: FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.
Quantity in commerce: 33 syringes
Distribution: Nationwide Distribution --- including states of FL, OH, TX, and UT.
Product codes and lots: Lot # A08F01E Exp Date 2010-06

Product code MQV

K053228Class IITherigraft Tcp Putty Bone Void FillerTherics, LLC / cleared 2006-01-31

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)