CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report
Integra Mozaik Putty 5cc, 5 cc, 10 cc recalled by Integra LifeSciences
Integra LifeSciences is recalling Integra Mozaik Putty 5cc, 5 cc, 10 cc. The recall was initiated on 11 Oct 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1796-2012
- FDA event ID
- 61717
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2011
- FDA classified
- 12 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Spinal Implants
Timeline
| 11 Oct 2011 | Recall initiated by company | |
| 12 Jun 2012 | Classified by FDA | +245 days |
| 20 Jun 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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,
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution
Questions about this recall
Is Integra Mozaik Putty 5cc, 5 cc, 10 cc recalled?
Yes. Integra LifeSciences recalled Integra Mozaik Putty 5cc, 5 cc, 10 cc on 11 Oct 2011. The recall is Class II and its status is Terminated. Recall number Z-1796-2012.
Why was it recalled?
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,
Which lots are affected?
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
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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