Reported Jun 3, 2020 · Ongoing

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail, M-Gait - Product Usage: is designed to…

Motek Medical B.v.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MOTEK MEDICAL B.V. · Hogehilweg 18 · Amsterdam, N/A · N/A

Is this the product you have?

Body Weight Support (BWS) Light; Model No. RB011; a component of C-Mill, Grail
M-Gait - Product Usageis 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

Lot codes and dates: 81 of 81 codes
AS9924-00-0002
RB011-00-0005
RB011-00-0006
RB011-00-0010
RB011-00-0012
RB011-00-0015
RB011-00-0017
RB011-00-0018
RB011-00-0019
RB011-00-0020
RB011-00-0021
RB011-0022
RB011-0023
RB011-0024
RB011-0025
RB011-0026
RB011-0027
RB011-0028
RB011-0029
RB011-0030
RB011-0031
RB011-0032
RB011-0033
RB011-0034
RB011-0035
RB011-0036
RB011-0037
RB011-0038
RB011-0039
RB011-0040
RB011-0041
RB011-0042
RB011-0044
RB011-0045
RB011-0046
RB011-0047
RB011-0048
RB011-0049
RB011-0050
RB011-0051
RB011-0052
RB011-0053
RB011-0054
RB011-0055
RB011-0056
RB011-0057
RB011-0058
RB011-0059
RB011-0060
RB011-0061
RB011-0062
RB011-0063
RB011-0064
RB011-0065
RB011-0066
RB011-0067
RB011-0068
RB011-0069
RB011-0070
RB011-0071
Amount recalled: 80 units

Where it was sold

Nationwide
AZ
CA
FL
KY
MA
MI
NJ
NY
NC
OH

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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