Recall Z-0785-2013— Invacare Corporation

Name: FDA recall Z-0785-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-10

Class II · Terminated

Class II FDA medical device recall by Invacare Corporation, initiated 2012-09-10, terminated 2014-05-13. It names one FDA 510(k) clearance: K984447. Product: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.. Reason: The potential exists for the wheel to rotate freely despite engagement of hub brake..

Recalling firm: Invacare Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-09-10
Terminated: 2014-05-13
Firm location: Elyria, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K984447 — MODEL ACTION AT II MANUAL WHEELCHAIRInvacare Corp.·cleared 1999-01-08

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

Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.

Reason for recall

The potential exists for the wheel to rotate freely despite engagement of hub brake.

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