Class II — Activbody, Inc.
| Recalling firm | ActivBody |
|---|---|
| Registered facility | ACTIVBODY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration. |
| Product | activforce 2 package labeling: Model: Activ5-M R 201-200563 |
| Quantity | 145 kits in U.S. |
| Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. O.U.S.: Not provided |
| Initiated | 2021-11-30 |
| Classified | 2021-12-16 |
| Recall number | Z-0386-2022 |
| 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 — Activbody, Inc. (Z-0386-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89070/
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