Events

Recall of Device Recall Permolock C3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Permobil Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61351
  • Event Risk Class
    Class 2
  • Event Number
    Z-1278-2012
  • Event Initiated Date
    2012-02-21
  • Event Date Posted
    2012-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107875
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Components, wheelchair - Product Code KNN
  • 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.
  • 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.

Device

Device Recall Permolock C3
  • Model / Serial
    2535004066, 2572002096, 2579000034, 2572000426, 2572000849, 2572002091, 2572000465, 2535004075, 2535005133, 2535005713, 2572000634, 2572000657, 2572000990, 2572001078, 2572001083, 2572001160, 2572001164, 2572001165, 2572001358, 2572001374, 2572001421, 2572001853, 2572002187, 2572003372, 2579000098, 2579000113, 2579000116, 2579000118, 2535005348, 2572001751, 2535005269, 2572000413, 2579000074, 2579000142, 2535003842, 2535003900, 2535003840, 2572002439, 2572002766, 2572003182,  XXX(missing), 2579000063, 2572000759, 2572002123, 2579000069, 2572001763, 2535004162, 2572001946, 2532000044, 2535003732, 2535005475, 2572002189, 2579000151, 2579000156, 2535005551, 2535005774, 2572001705, 2579000089, 2539000224, 43203318, 2579000143, 2535004819, 2572002020, 2572002080, 2572002169, 2572002417, 2579000127, 2572000754, 2572001116, 2572001646, 2572001852, 2573000016, 2573000027, 2573000028, 2573000029, 2535004353, 2535004564, 2535004586, 2539000222, 2539000277, 2539000310, 2539000344, 2572000639, 2572001038, 2572001445, 2572001631, 2572001981, 2572002686, 2579000067, 2535005151, 2535005113, 2572002831, 2572002863, 2535005645, 2535005730, 2539000263, 2572000826, 2572002659, 2535004730, 2535005300, 2535005579, 2572000688, 2572002040, 2572002801, 2535003865, 2535004016, 2535005131, 2572002425, 2579000082, 2535004413, 2535005463, 2572000540, 2535004285, 2572003051, 2535005557, 2572003293, 2579000045, 2572000785, 2532000016, 2535004732, 2572001708, 2572002155, 2572000424, 2535004060, 2535003525, 2572000552, 2572001632, 2572002511, 2572002519, 2572001711, 2535004620, 2572001807, 2535004136, 2572002062, 2572003093, 2572001549, 2572002110, 2572002599, 2572002694, 2535005406, 2572001821, 2535004688, 2535004912, 2572000894,2572003240, 2579000090, 2539000332
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product Description
    Permolock C3, Docking system for Power wheelchair in vehicle. || Intended use: locking device
  • Manufacturer
    Permobil Inc

Manufacturer

Permobil Inc
  • Manufacturer Address
    Permobil Inc, 300 Duke Drive, Lebanon TN 37090-6005
  • Manufacturer Parent Company (2017)
    Investor AB
  • Source
    USFDA