medical Class II Updated 2020-06-10

Osteomed, LLC recalls OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/008138450

Recalled Product

OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - 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 17102713, 1156491, 17051907, 1136327 and 1126984
View official government recall

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