Class 2 Device Recall Solara 3G Custom Manual Wheelchair

• Date Initiated by Firm: September 10, 2012
• Date Posted: February 04, 2013
• Recall Status: Terminated on May 13, 2014
• Recall Number: Z-0785-2013
• Recall Event ID: 64044
• 510(K)Number: K984447
• Product Classification: Wheelchair, mechanical - Product Code IOR
• Product: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
• Code Information: Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.
• Recalling Firm/ Manufacturer: Invacare Corporation; 1 Invacare Way; Elyria OH 44035-4190
• For Additional Information Contact: 440-329-6595
• Manufacturer Reason for Recall: The potential exists for the wheel to rotate freely despite engagement of hub brake.
• FDA Determined Cause: Process control
• Action: Invacare sent an URGENT: RECALL INFORMATION Letter dated September 10, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1) Complete the Provider Response Card indicating your receipt and understanding of these instructions. 2) Contact your customers to inform them of the recall. It is recommended that you provide them with the enclosed Customer Letter. Set up an appointment to correct the customer's wheelchair as soon as possible. 3) Please examine the wheelchair to confirm it has one of the serial numbers listed above. The serial number can be found on the front lower crossbar located on the right while sitting in the chair. 4) Using the enclosed retrofit kit, make the necessary correction. Installation instructions can be found on page 109 of the Solara service manual, which is enclosed. 5) Document the correction of the wheelchair on the enclosed tracking sheet. 6) Using the enclosed pre-paid UPS mailing label and original box, return the replaced parts to the address listed on the label. 7) Fax or email the Provider Response Form and tracking sheet to 330-329-3458 or recall@invacare.com. For questions please contact Invacare Customer Service at 800-333-6900.
• Quantity in Commerce: 3 units
• Distribution: US Nationwide Distribution including the states of CA & MT.
• 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 = IOR