Integra Mozaik Putty Recalled for Incorrect Instructions for Use Translation
Integra LifeSciences Corp. is recalling 42 units of Mozaik Putty because the Instructions for Use contain incorrect Spanish and French translations of the term 'bone marrow aspirate'.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and translation error in the Instructions for Use without reported injuries or illnesses, fitting the rubric criteria for cosmetic defects or documentation issues.
Plain-English summary
Integra LifeSciences Corp. is recalling 42 units of Integra Mozaik Putty (2.5cc, 5 cc, and 10 cc) due to a labeling error in the Instructions for Use. The product is a bone graft substitute composed of collagen and ceramic matrix intended for use as a bone void filler.
The recall is triggered by an incorrect translation of the term "bone marrow aspirate" in the Spanish and French versions of the Instructions for Use for the CE marked Mozaik Strip and Putty products. The source text does not report any illnesses, injuries, or adverse health consequences associated with this labeling error.
The affected units are identified by specific batch numbers and reference numbers for the 2.5cc, 5cc, and 10cc putty variants. The source text indicates worldwide distribution. Consumers and healthcare providers should verify their product lot numbers against the recall details and contact the manufacturer for further instructions.
The recalled product
- 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…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 42
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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