Z-2657-2014 Class II Terminated
FDA device recall Z-2657-2014 was initiated by Motion Concepts on August 28, 2014 and is designated Class II. Reason for recall: Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner). The recall status is terminated (terminated June 3, 2015). Affected quantity: US: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 24, 2014
- Initiation Date
- August 28, 2014
- Termination Date
- June 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 59 units
Product Description
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System.
Reason for Recall
Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of two attachment bolts in the Vertical Position System (TRx Vertical Positioner).
Distribution Pattern
US Distribution in states of: AR, CA, CT, DE, IA, ID, IL, IN, MI, MD, MO, NE, NY, OH, PA, TN, TX, and WA.
Code Information
All units manufactured between June 2011 and May 2014: Serial Numbers 28583, 28597, 28604, 28607, 28629, 30334, 028380, U001050, U001083, U001544, U002020, U002326, U002386, U002403, U002411, U002489, U002502, U002505, U002509, U002510, U002519, U002716, U002922, U003577, U004011, U004018, U004073, U004079, U004145, U004214, U004400, U004404, U004472, U004485, U006042, U006234, U006235, U006260, U006295, U006296, U006353, U006378, U007126, U007138, U007163, U007239, U007245, U007279, U007288, U007407, U008556, U008631, U008698, U008840, U008896, U009548, U009569, U009579, U009707, U009718.