Activbody, Inc. recalls activforce 2 package labeling: Model: Activ5-M R 201-200563

Recall date

November 30, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0386-2022

FDA classification

Class II

Brand / firm

Activbody, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

activforce 2 package labeling: Model: Activ5-M R 201-200563