Osteomed, LLC: Medical Device Recall in 2020 - (Recall #: Z-2185-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 2, 2020

Date Posted: June 10, 2020

Recall Number: Z-2185-2020

Event ID: 85529

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.

Status: Terminated

Product Quantity: 300

Code Information:

LOT 1128788, 1133246, 1126985 and 1135313

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.

Voluntary or Mandated:

Voluntary: Firm initiated