FDA-Device2021-12-22Class II
activforce 2 package labeling: Model: Activ5-M R 201-200563
Activbody, Inc.
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.
Sold states
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
Affected count
145 kits in U.S.
Manufactured in
4435 Eastgate Mall, San Diego, CA, United States
Products
activforce 2 package labeling: Model: Activ5-M R 201-200563
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0386-2022Don't want to check this manually?
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