FDA-Device2020-06-10Class II
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Osteomed, LLC
Hazard
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA. MA, MD, ME. MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY and the countries of AUSTRALIA, ITALY, KOREA, MALAYSIA, PERU, SINGAPORE and THAILAND.
Affected count
1724
Manufactured in
3885 Arapaho Rd, N/A, Addison, TX, United States
Products
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2188-2020Don't want to check this manually?
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