FDA Device recall Z-0386-2022
activforce 2 package labeling: Model: Activ5-M R 201-200563
- FDA Device
- Class II
- ongoing
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of activforce 2 package labeling: Model: Activ5-M R 201-200563 by Activbody, citing 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 li….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0386-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-30 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Activbody |
| Distribution | 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, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
activforce 2 package labeling: Model: Activ5-M R 201-200563
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.
Identifiers
| code_info | Activforce 2 Serial Numbers: 5M1011012046AK7655 5M1011012046AK7556 5M1011012046AK7557 5M1011012046AK7559 5M1011012046AK…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 5M |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0386-2022%22
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