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U.S. Department of Health and Human Services

Class 3 Device Recall OsSatura TCP

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 Class 3 Recall
OsSatura TCP
see related information
Date Posted February 22, 2007
Recall Status1 Open
Recall Number Z-0423-2007
Recall Event ID 36974
Premarket Notification
510(K) Number
K031826 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
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
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
For Additional Information Contact J.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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = TEKNIMED SA
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