Recall Z-2695-2014— Pdg Product Design Group Inc

Name: FDA recall Z-2695-2014
Creator: U.S. Food and Drug Administration
Published: 2012-06-12

Class II · Terminated

Class II FDA medical device recall by Pdg Product Design Group Inc, initiated 2012-06-12, terminated 2015-07-23. It names one FDA 510(k) clearance: K063736. Product: Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr. Reason: The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use..

Recalling firm: Pdg Product Design Group Inc
Classification: Class II
Status: Terminated
Initiated: 2012-06-12
Terminated: 2015-07-23
Firm location: Vancouver, British Columbia, Canada

510(k) clearances named in this recall

1 on FDA's record

K063736 — FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50Pdg Product Design Group, Inc.·cleared 2007-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr

Reason for recall

The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.