medical Class II Updated 2020-06-10

Osteomed, LLC recalls OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020

Recalled Product

OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

Hazard / Issue

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: LOT 17051908, 17060107, 1132179, 1133245, 1135308 and 1142208
View official government recall

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