Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type
FDA device recall Z-1796-2012 · posted 2012-06-12 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- 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,
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 42 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-10-11
- Date posted
- 2012-06-12
- Date terminated
- 2013-02-14
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOZAIK BONE REGENERATION MATRIX - PUTTY (K062353) | Integra LifeSciences Corporation | 2006-12-20 |