Enforcement Report - Week of June 20, 2012
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Product Detail
| Product Description | Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (IP3-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. |
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| Recall Number | Z-1796-2012 |
| Classification | Class II |
| Code Info | Putty Part Number 7700713001 510 K- K062353 Device Listing Number - E604163 Integra MOZAIKTM Putty 2.5cc Reference No. - PTY10125ITL Batch number - 105BR02l5949 Integra MOZAIKTM Putty 5cc Refernce No. - PTY10155ITL Batch No. - 105BR0216024 Integra MOZAIKTM Putty lOcc Reference No.- PTY10210ITL Batch No. - 105BR0215956 |
| Product Distributed Qty | 42 units |
| Reason For Recall | The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l 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, |
Event Detail
| Event Id | 61717 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Integra LifeSciences Corp. |
| City | Plainsboro |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-10-11 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution |
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