| |
Class 3 Device Recall Mechanical Chair With Casters |
 |
| Date Initiated by Firm |
November 19, 2021 |
| Create Date |
January 07, 2022 |
| Recall Status1 |
Terminated 3 on October 31, 2022 |
| Recall Number |
Z-0467-2022 |
| Recall Event ID |
89204 |
| Product Classification |
Chair, with casters - Product Code INM
|
| Product |
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU
The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport. |
| Code Information |
Model No.: TYK; Serial No: TYK0000500, TYK0000501, TYK0000502, TYK0000503, TYK0000504, TYK0000506, TYK0000505, TYK0000507, TYK0000508, TYK0000509, TYK0000510, TYK0000512, TYK0000511, TYK0000513, TYK0000517, TYK0000520, TYK0000518, TYK0000514, TYK0000515, TYK0000519, TYK0000516, TYK0000521, TYK0000522, TYK0000525, TYK0000524, TYK0000526, TYK0000527, TYK0000528, TYK0000530, TYK0000529, TYK0000531, TYK0000532, TYK0000534; UDI: (01)00850013379231(11)2021-04-05(21)TYK0000500, (01)00850013379231(11)2021-04-12(21)TYK0000501, (01)00850013379231(11)2021-04-13(21)TYK0000502, (01)00850013379231(11)2021-04-19(21)TYK0000503, (01)00850013379231(11)2021-04-29(21)TYK0000504, (01)00850013379231(11)2021-06-11(21)TYK0000505, (01)00850013379231(11)2021-06-11(21)TYK0000507, (01)00850013379231(11)2021-06-11(21)TYK0000508, (01)00850013379231(11)2021-07-08(21)TYK0000509,(01)00850013379231(11)2021-07-08(21)TYK0000510, (01)00850013379231(11)2021-06-11(21)TYK0000512, (01)00850013379231(11)2021-07-14(21)TYK0000511, (01)00850013379231(11)2021-08-06(21)TYK0000513, (01)00850013379231(11)2021-08-06(21)TYK0000517, (01)00850013379231(11)2021-08-06(21)TYK0000520, (01)00850013379231(11)2021-08-06(21)TYK0000518, (01)00850013379231(11)2021-08-06(21)TYK0000514, (01)00850013379231(11)2021-08-06(21)TYK0000515, (01)00850013379231(11)2021-08-06(21)TYK0000519, (01)00850013379231(11)2021-08-06(21)TYK0000516, (01)00850013379231(11)2021-08-16(21)TYK0000521, (01)00850013379231(11)2021-09-02(21)TYK0000522, (01)00850013379231(11)2021-09-20(21)TYK0000525, (01)00850013379231(11)2021-09-20(21)TYK0000524, (01)00850013379231(11)2021-10-04(21)TYK0000526, (01)00850013379231(11)2021-10-04(21)TYK0000527, (01)00850013379231(11)2021-10-12(21)TYK0000528, (01)00850013379231(11)2021-10-29(21)TYK0000530, (01)00850013379231(11)2021-10-29(21)TYK0000529, (01)00850013379231(11)2021-11-16(21)TYK0000531, (01)00850013379231(11)2021-11-17(21)TYK0000532, (01)00850013379231(11)2021-11-17(21)TYK0000534.
|
Recalling Firm/
Manufacturer |
Ki Mobility Llc
5201 Woodward Dr
Stevens Point WI 54481
|
| For Additional Information Contact |
Mark Murphy
715-303-6447
|
Manufacturer Reason
for Recall |
The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.
|
FDA Determined
Cause 2 |
Process design |
| Action |
The firm distributed a Medical Device Correction Notice dated 12/07/2021 by first class mail to consignees. The notificaiton identified the reason for recall as the Owner's Manual/Instructions for Use for the Little Wave Tyke contained information intended for a mechanical wheelchair, not a mechanical chair with casters. Customers were instructed to distribute the provided updated Little Wave Tyke Owner's Manual/Instructions for Use (DCN0569.2) to end users, and if available request that customers destroy or dispose of the previous versions of the manual (DCN0569.0 and DCN0569.1). The updated manual is available in print or on the company's website (kimobility.com). Customers with any questions are asked to contact the firm by email at sales@kimobility.com, or by phone at (715)254-0991 or (800)981-1540.
|
| Quantity in Commerce |
33 units shipped with affected manuals |
| Distribution |
Domestic: IL, IN, KY, MI, MO, NC, SC, and TN. |
| 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.
|
|
|
|
