Integra Mozaik Strip Recalled for Incorrect Instructions for Use Translation
Integra LifeSciences Corp. is recalling Integra Mozaik Strip units because the Instructions for Use contain incorrect Spanish and French translations of the term "bone marrow aspirate."
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and translation error in the Instructions for Use, which falls under the 'Low' severity criteria for packaging or documentation-only problems without reported harm.
Plain-English summary
Integra LifeSciences Corp. is recalling 22 units of Integra Mozaik Strip, a bone graft substitute composed of collagen and ceramic matrix. The product is intended for use as a bone void filler in the skeletal system. The recall is limited to specific batch numbers: 105BR0215955 and 105BR0216149.
The reason for the recall is that the Instructions for Use (IFU) for the CE marked Mozaik Strip and Putty products contain an incorrect translation of the term "bone marrow aspirate" in Spanish and French. This is a documentation and labeling issue affecting the accuracy of the provided instructions.
The affected products were distributed worldwide. Consumers and healthcare providers should stop using the affected units and contact the manufacturer for further instructions or replacement.
The recalled product
- 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
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 22
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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