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Terminated

Kuschall K Junior Manual wheelchair

FDA Recall Z-0421-2010 · Posted 2009-11-25

Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeIOR
Date Initiated2009-06-15
Date Terminated2011-11-21
Product Quantity20 Wheelchairs

Reason for Recall

The handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).

Firm Action

The firm contacted their customers by telephone and then sent a recall notification letter to each customer on 6/15/2009. Questions are directed to email: [email protected] or phone: 800-333-6900.

Root Cause

Device Design

Distribution Pattern

Product was distributed to the following states: CA, CO, MN, NJ, OR, PA, TX & VA and one to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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