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TiLite ZR and ZRA Series 2 are mechanical wheelchairs.… recallZ-3161-2011 · TiSport, Llc · initiated Jul 5, 2011

Terminated All recalls posted in September 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from TiSport, Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-3161-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 5, 2011
Posted by the FDA
Sep 7, 2011
Recalling firm
TiSport, Llc
Quantity
1,037 units
Product code
IOR
FDA submissions
K990358
Distribution
Worldwide Distribution

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (8k characters)

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Other devices under the same FDA submission

3 devices cleared under K990358 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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