Recall Z-1278-2012 ยท KNN Components, Wheelchair
Permobil Inc
Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device
| Date | Mar 22, 2012 (initiated Feb 21, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Mixed-up of materials/components |
| 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. |
| Quantity | 147 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041219 | ELECTRO Permobil AB, Aug 4, 2004 |