Recall Z-0386-2022 ยท LBB Dynamometer, Ac-Powered
Activbody, Inc.
activforce 2 package labeling: Model: Activ5-M R 201-200563
| Date | Nov 30, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| Action | On 11/19/2021, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers and followed up with a hardcopy letter on 11/30/2021 via US Postal Service, to inform them that the firm failed to register with the U.S. Food and Drug Administration and therefore must be recalled from the market, and the risk of using the affected products can result in Inaccurate force measurements may result from using these devices. If inaccurate measurements are used to judge rehabilitation progress, the most immediate consequence is an increased risk of re-injury to the patient. Customers are instruc |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.