| Class 3 Device Recall OsSatura TCP | |
Date Initiated by Firm | August 31, 2006 |
Date Posted | February 22, 2007 |
Recall Status1 |
Terminated 3 on April 23, 2012 |
Recall Number | Z-0423-2007 |
Recall Event ID |
36974 |
510(K)Number | K031826 |
Product Classification |
bone void filler - Product Code MQV
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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 France
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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 | 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 |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MQV
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