[Recalled] 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 bon
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 extre |
|---|---|
| Brand / manufacturer | Integra LifeSciences Corp. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1795-2012 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 October 2011 |
| EAN / barcode | 7701513001 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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,
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.