Recall Z-3161-2011 ยท IOR Wheelchair, Mechanical
TiSport, Llc
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.
| Date | Sep 7, 2011 (initiated Jul 5, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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 encl |
| Quantity | 1,037 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990358 | CROSS SPORT, RIGID WHEELCHAIR Tisport, Feb 26, 1999 |