medical Class II Updated 2020-06-10

Osteomed, LLC recalls OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845

Recalled Product

OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - 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 1128523, 1129958, 1135746, 1142073, 17071104, 17100404 and 1126669
View official government recall

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