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Integra LifeSciences Corp. recalls Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) an
Recalled June 20, 2012 · FDA recall Z-1795-2012 · Integra LifeSciences
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, · FDA Class II
Units
22 units
Sold at
Worldwide Distribution
Description
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,
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 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.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →