Device product
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
Z-1795-2012
Product summary
- Event
- Event 61717
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-1795-2012
Official wording
Reason: The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,
Code information: Strip Part Number 7701513001 510 K- K063124 Device Listing Number - D001098 Integra MOZAIKTM Strip IOcc Reference number - CCM I021OITL Batch Number - 105BR0215955 Integra MOZAIKTM Strip 10cc Reference Number - CCM I021OITL Batch Number - 105BR0216149
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,