Integra LifeSciences Corp.: Medical Device Recall in 2012 - (Recall #: Z-1795-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 11, 2011

Date Posted: June 20, 2012

Recall Number: Z-1795-2012

Event ID: 61717

Reason for Recall:

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,

Status: Terminated

Product Quantity: 22 units

Code Information:

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

Distribution Pattern:

Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated