Z-1796-2012Class II

Integra Mozaik Putty 2.5cc, 5 cc, 10 cc

Name: Z-1796-2012 Integra Mozaik Putty 2.5cc, 5 cc, 10 cc
Creator: Integra LifeSciences Corp.
Published: 2011-10-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-10-11 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2011-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1796-2012
Classification: Class II
Status: Terminated
Initiated: 2011-10-11
Posted: 2012-06-12
Terminated: 2013-02-14
Recalling firm: Integra LifeSciences Corporation
Product: 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.
Product code: MQV Filler, Bone Void, Calcium Compound
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,
Root cause tag: manufacturing process
FDA root cause: Employee error
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].
Quantity in commerce: 42 units
Distribution: Worldwide Distribution
Product codes and lots: Putty Part Number 7700713001 510 K- K062353 Device Listing Number - E604163 Integra MOZAIKTM Putty 2.5cc Reference No. - PTY10125ITL Batch number - 105BR02l5949 Integra MOZAIKTM Putty 5cc Refernce No. - PTY10155ITL Batch No. - 105BR0216024 Integra MOZAIKTM Putty lOcc Reference No.- PTY10210ITL Batch No. - 105BR0215956

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1796-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1795-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-12
Z-1796-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-12

Product code MQV

K062353Class IIMozaik Bone Regeneration Matrix - PuttyIntegra LifeSciences Corporation / cleared 2006-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)