OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100
FDA device recall Z-0423-2007 · posted 2007-02-22 · Terminated
Recall details
- Recalling firm
- Teknimed SA
- Reason for recall
- The firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 1681 units
- Distribution
- Nationwide
- Date initiated
- 2006-08-31
- Date posted
- 2007-02-22
- Date terminated
- 2012-04-23
- Location
- France
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIHA + (K031826) | Teknimed, S.A. | 2003-11-28 |