FDAFDA · Food and drugs·Recall number Z-1795-2012
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.
Published June 20, 2012 · Recall initiated: October 11, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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,
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp.
- Distributor
- Worldwide Distribution
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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