Recall Z-0423-2007 ยท MQV Filler, Bone Void, Calcium Compound
Teknimed SA
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
| Date | Feb 22, 2007 (initiated Aug 31, 2006) |
| Status | Terminated |
| Reason | The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box. |
| 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 Instru |
| Quantity | 1681 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031826 | TRIHA + Teknimed, S.A., Nov 28, 2003 |