Integra Mozaik Strip 10 cc Product Usage: The product recall
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate)…
Why was Integra Mozaik Strip 10 cc Product Usage: The product recalled?
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 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?
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
- 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)…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 22 units
- Distribution
- Worldwide Distribution
- Recall date
- June 20, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)