FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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.
- Recall number
- Z-1795-2012
- Recalling firm
- Integra LifeSciences Corp.
- 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.
- Status
- Terminated
- Initiated
- 2011-10-11
- Posted
- 2012-06-12
- Terminated
- 2013-02-14
- Reason
- 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,
- 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: carole.robin@integralife.com.
- Quantity
- 22 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K063124"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28