Z-0423-2007

OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc...

Name: Z-0423-2007 OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc...
Creator: Teknimed SA
Published: 2006-08-31
License: https://open.fda.gov/license/

Teknimed SAS / initiated 2006-08-31 / Terminated / root cause: labeling and UDI

FDA source

Teknimed SA began a recall of OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300... on 2006-08-31. The reason FDA records is "The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box". 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-0423-2007
Status: Terminated
Initiated: 2006-08-31
Posted: 2007-02-22
Terminated: 2012-04-23
Recalling firm: Teknimed SAS
Product: OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Teknimed notified IsoTis OrthoBiologics via electronic recall letter dated August 31, 2006. IsoTis was instructed to notify their consignees of this field correction and they were asked to be responsible for identifying and making any corrections necessary at the medical user level. Teknimed supplied the correct IFU to IsoTis so that they could perform a field correction of the affected product. October 1, 2006 IsoTis OrthoBiologics sent their consignees a recall notification that included the IsoTis notification letter, a copy of the Teknimed recall letter, IsoTis Field Correction Instruction Sheet and replacement TCP IFU's for the affected lots.
Quantity in commerce: 1681 units
Distribution: Nationwide
Product codes and lots: Batch numbers shipped to US: 82/0415, 82/04474, 82/05062, 82A/05454, 82/04172, 82/04264, 82/04274, 82/04472, 82/04511, 82/05052, 82A/0526, 82A/05404, 82A/0619, 82/04182, 82/04204, 82/04252, 82A/05452, 82A/06014, 82A/0620, 82/04194, 82/04242, 82/04492 & 82A/06024

Product code MQV

K031826Class IITriha +Teknimed, S.A. / cleared 2003-11-28

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)