Recall Z-1266-2014— Bock,Otto,Orthopedic Ind,Inc
Class II · Terminated
Class II FDA medical device recall by Bock,Otto,Orthopedic Ind,Inc, initiated 2014-01-31, terminated 2018-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.. Reason: Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed..
- Recalling firm
- Bock,Otto,Orthopedic Ind,Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-31
- Terminated
- 2018-05-07
- Firm location
- Minneapolis, MN, United States
Product description
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.
Reason for recall
Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.