Recall Z-0386-2022
Activbody, Inc. · initiated November 30, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
activforce 2 package labeling: Model: Activ5-M R 201-200563
Codes / lots: Activforce 2 Serial Numbers: 5M1011012046AK7655 5M1011012046AK7556 5M1011012046AK7557 5M1011012046AK7559 5M1011012046AK7560 5M1011012046AK7561 5M1011012046AK7562 5M1011012046AK7563 5M1011012046AK7564 5M1011012046AK7565 5M1011012046AK7566 5M1011012046AK7567 5M1011012046AK7568 5M1011012046AK7569 5M1011012046AK7570 5M1011012046AK7571 5M1011012046AK7572 5M1011012046AK7573 5M1011012046AK7574 5M1011012046AK7575 5M1011012046AK7576 5M1011012046AK7577 5M1011012046AK7578 5M1011012046AK7579 5M1011012046AK7580 5M1011012046AK7581 5M1011012046AK7582 5M1011012046AK7583 5M1011012046AK7584 5M1011012046AK7585 5M1011012046AK7586 5M1011012046AK7587 5M1011012046AK7588 5M1011012046AK7589 5M1011012046AK7590 5M1011012046AK7591 5M1011012046AK7592 5M1011012046AK7593 5M1011012046AK7594 5M1011012046AK7595 5M1011012046AK7596 5M1011012046AK7597 5M1011012046AK7598 5M1011012046AK7599 5M1011012046AK7600 5M1011012046AK7601 5M1011012046AK7602 5M1011012046AK7603 5M1011012046AK7604 5M1011012046AK7605 5M1011012046AK7606 5M1011012046AK7607 5M1011012046AK7608 5M1011012046AK7609 5M1011012046AK7610 5M1011012046AK7611 5M1011012046AK7612 5M1011012046AK7613 5M1011012046AK7614 5M1011012046AK7615 5M1011012046AK7616…
Reason for recall
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-determined cause: Other
Action taken
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 support@activbody.com
Details
- Recall number
- Z-0386-2022
- Initiated
- November 30, 2021
- Product code
- LBB – Dynamometer, Ac-Powered
- 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
- Recalling firm
- Activbody, Inc., San Diego, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0385-2022 Class II | Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5…Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential… | 11/30/2021Open, Classified |