Class II — Osteomed, LLC
| Recalling firm | OSTEOMED |
|---|---|
| Registered facility | OSTEOMED (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration. |
| Product | OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process. |
| Quantity | 995 |
| Distribution | 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. |
| Initiated | 2020-04-02 |
| Classified | 2020-05-29 |
| Terminated | 2021-05-05 |
| Recall number | Z-2190-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Osteomed, LLC (Z-2190-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85529/
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