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Terminated

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 (IP3-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.

FDA Recall Z-1796-2012 · Posted 2012-06-12

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeMQV
Date Initiated2011-10-11
Date Terminated2013-02-14
Product Quantity42 units

Reason for Recall

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,

Firm Action

Integra LifeSciences sent a Field Safety Notice letter dated October 11, 2011 to their sole foreign consignee. The letter identified the affected products, problem and actions to be taken. The consignee was asked to remove the existing Instructions for Use (IFU) and replace it with the corrected IFU. The consignee was instructed to complete and return the attached Distributor Rework and Acknowledgment Forms provided with the customer notification letter as documentation that instructions were followed and all required actions were completed. For any questions, call: +33 (0)4 37 47 5900 , fax: +33 (0)4 37 47 5999; or email: [email protected].

Root Cause

Employee error

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062353MOZAIK BONE REGENERATION MATRIX - PUTTYIntegra LifeSciences Corporation · 2006-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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