Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device
FDA Recall Z-1278-2012 · Posted 2012-03-22
Recalling FirmPermobil Inc
Recall StatusTerminated
Product CodeKNN
Date Initiated2012-02-21
Date Terminated2013-08-13
Product Quantity147 units
Reason for Recall
The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment.
Firm Action
The firm, Permobil, sent an "URGENT DEVICE RECALL" letter dated February 27, 2012 via fax to all customers. For those customers where Permobil did not have a valid fax number, the notices were mailed via first class United States mail. The letter describes the product, problem and actions to be taken. Permobil will designate Permobil personnel to complete an update to the Permolock C3 device.
If a Permobil representative has not contacted you already, please call 800-736-0925 to schedule the service.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, MD ,MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WV, and WY; and countries of: Australia, Canada, France, Netherlands, Sweden, and United Kingdom.
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.