Z-2182-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 2, 2020
- Termination Date
- May 5, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 647
Product Description
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.
Reason for Recall
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Distribution Pattern
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.
Code Information
LOT 1128523, 1129958, 1135746, 1142073, 17071104, 17100404 and 1126669