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U.S. Department of Health and Human Services

Class 3 Device Recall OsSatura TCP

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 Class 3 Device Recall OsSatura TCPsee related information
Date Initiated by FirmAugust 31, 2006
Date PostedFebruary 22, 2007
Recall Status1 Terminated 3 on April 23, 2012
Recall NumberZ-0423-2007
Recall Event ID 36974
510(K)NumberK031826 
Product Classification bone void filler - Product Code MQV
ProductOsSatura 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
Code Information 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
Recalling Firm/
Manufacturer		 Teknimed SA
11 Rue Apollo
L France
For Additional Information ContactJ.D. Webb
512-388-0199
Manufacturer Reason
for Recall		The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.
FDA Determined
Cause 2		Other
ActionTeknimed 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 Commerce1681 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MQV
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