medical Class II Updated 2020-06-10

Osteomed, LLC recalls OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /008138

Recalled Product

OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - 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 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902 and 1142212
View official government recall

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