Z-2185-2020 Class II Terminated
FDA device recall Z-2185-2020 was initiated by Osteomed, LLC on April 2, 2020 and is designated Class II. 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. The recall status is terminated (terminated May 5, 2021). Affected quantity: 300.
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
- 300
Product Description
OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - 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 1128788, 1133246, 1126985 and 1135313