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U.S. Department of Health and Human Services

Class 2 Device Recall TiLite ZR Series 2 and ZRA Series 2 Wheelchairs

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 Class 2 Device Recall TiLite ZR Series 2 and ZRA Series 2 Wheelchairssee related information
Date Initiated by FirmJuly 05, 2011
Date PostedSeptember 07, 2011
Recall Status1 Terminated 3 on July 27, 2012
Recall NumberZ-3161-2011
Recall Event ID 59305
510(K)NumberK990358 
Product Classification Mechanical Wheelchair - Product Code IOR
ProductTiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. The TiLite ZR had a model catalog number of Z2FS1. The TiLite ZRA has a model catalog number of Z2FS2. Provide mobility for physically impaired individuals.
Code Information 52359, 52493, 52501, 52532, 52552, 52586, 52588, 52590, 52632, 52689, 52700, 52718, 52722, 52737, 52740, 52754, 52760, 52778, 52785, 52792, 52804, 52820, 52824, 52830, 52833, 52836, 52842, 52847, 52856, 52862, 52874, 52875, 52879, 52899, 52911, 52918, 52924, 52926, 52951, 52958, 52978, 52979, 52982, 52994, 52997, 52998, 52999, 53008, 53014, 53034, 53038, 53048, 53051, 53070, 53089, 53094, 53111, 53120, 53123, 53146, 53163, 53174, 53186, 53206, 53209, 53219, 53222, 53236, 53242, 53250, 53254, 53256, 53258, 53259, 53260, 53265, 53267, 53270, 53274, 53276, 53285, 53286, 53287, 53290, 53294, 53295, 53299, 53303, 53316, 53335, 53343, 53396, 53427, 53436, 53444, 53454, 53458, 53465, 53467, 53487, 53490, 53493, 53497, 53504, 53509, 53511, 53520, 53525, 53526, 53533, 53534, 53542, 53543, 53547, 53551, 53555, 53564, 53569, 53570, 53580, 53585, 53591, 53610, 53635, 53641, 53660, 53674, 53695, 53711, 53713, 53723, 53727, 53734, 53740, 53756, 53780, 53790, 53794, 53800, 53801, 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Recalling Firm/
Manufacturer		 TiSport, Llc
2701 W Court St
Pasco WA 99301-3911
For Additional Information ContactTechnical Support
509-586-6117
Manufacturer Reason
for Recall		The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off.
FDA Determined
Cause 2		Component design/selection
ActionAn Urgent Medical Device Correction letter, Product Correction Kit , and the Installation Instructions were sent to domestic suppliers, international suppliers, Veterans Administration hospitals and international distributors by US Priority Mail and by FedEx three days service. The letter identified the affected product and the reason for the recall. Customers were instructed not to send the product to their end user until the correction was made or to identify their end user and notify the end user of the product correction. Replacement parts and instructions to correct the issue were enclosed with the letter. Customers were to destroy the removed parts once they had completed the correction. Customers were to also return the Medical Device Correct Report that was provided, by fax to 509-586-2413, or email to ProdCorrection@tilite.com. Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.
Quantity in Commerce1,037 units
DistributionWorldwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IOR
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