TiLite 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.

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.

An 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 [email protected]. Customers can call Technical Support at 800-545-2266, ext. 239 with any questions about recall.