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U.S. Department of Health and Human Services

Class 2 Device Recall Permolock C3

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  Class 2 Device Recall Permolock C3 see related information
Date Initiated by Firm February 21, 2012
Date Posted March 22, 2012
Recall Status1 Terminated 3 on August 13, 2013
Recall Number Z-1278-2012
Recall Event ID 61351
510(K)Number K041219  
Product Classification Components, wheelchair - Product Code KNN
Product Permolock C3, Docking system for Power wheelchair in vehicle.

Intended use: locking device
Code Information 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  
Recalling Firm/
Manufacturer		 Permobil Inc
300 Duke Drive
Lebanon TN 37090-6005
For Additional Information Contact Darin Lowery
800-736-0925
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNN and Original Applicant = PERMOBIL A.B.
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