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Activbody, Inc. recalls activforce 2 package labeling: Model: Activ5-M R 201-200563
Recalled December 22, 2021 · FDA recall Z-0386-2022 · Activbody
Hazard
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. · FDA Class II
Units
145 kits in U.S.
Sold at
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
Description
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
Manufacturer(s)
Activbody, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →