Integra Mozaik Putty 2.5cc recall
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…
Why was Integra Mozaik Putty 2.5cc recalled?
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,
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 42 units
- Distribution
- Worldwide Distribution
- Recall date
- June 20, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)