Class II — MOTEK MEDICAL B.V.
| Recalling firm | MOTEK MEDICAL B.V. |
|---|---|
| Registered facility | MOTEK MEDICAL B.V. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide. |
| Product | Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to facilitate functional gait training of subjects with gait and/or balance impairment by providing dynamic partial vertical unloading during walking on a treadmill. The device will be used as an assistive device for gait deficiency rehabilitation and research purposes. |
| Quantity | 80 units |
| Distribution | Worldwide distribution - US Nationwide distributions including in the states of AZ, CA, FL, KY, MA, MI, NJ, NY, NC, and OH. The countries of Argentina, Austria, Belgium, China, Curacao, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Switzerland, and United Arab Emirates. |
| Initiated | 2019-07-29 |
| Classified | 2020-05-27 |
| Recall number | Z-2135-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MOTEK MEDICAL B.V. (Z-2135-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85301/
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