Recall Z-2135-2020— MOTEK MEDICAL B.V.
Class II · Ongoing
Class II FDA medical device recall by MOTEK MEDICAL B.V., initiated 2019-07-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- MOTEK MEDICAL B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-07-29
- Firm location
- Amsterdam, N/A, Netherlands
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.