activforce 2 package labeling: Model: Activ5-M R 201-200563
Recall
- Recall Number
- Z-0386-2022
- Event Number
- 89070
- Firm
- Activbody, Inc.
- FEI Number
- 3015316271
- Product Code
- LBB
- Status
- Open, Classified
- Root Cause
- Other
- Initiated
- November 30, 2021
- Address
- 4435 Eastgate Mall, San Diego, CA, 92121-1982
Description
activforce 2 package labeling: Model: Activ5-M R 201-200563
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.
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 instructed to: 1. Cease all use of these devices immediately. Use alternative methods and tools, such as manual muscle testing to measure force and/or a goniometer to measure range of motion. 2. Fill out the RECALL RETURN RESPONSE form. 3. Return the RECALL RETURN RESPONSE form and all devices in their possession to the Recalling Firm using the included pre-paid envelope. Customers only need to return the handheld dynamometer unit. Do not return the case, packaging or any accessories. For questions, contact support team via [email protected]
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
145 kits in U.S.