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Z-1266-2014 Class II Terminated

Recalled by Bock,Otto,Orthopedic Ind,Inc — Minneapolis, MN

FDA device recall Z-1266-2014 was initiated by Bock,Otto,Orthopedic Ind,Inc on January 31, 2014 and is designated Class II. 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 cu… The recall status is terminated (terminated May 7, 2018). Affected quantity: 464 units (US 113, OUS 351).

Recall Details

Product Type: Devices
Report Date: March 26, 2014
Initiation Date: January 31, 2014
Termination Date: May 7, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 464 units (US 113, OUS 351)

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.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Bosnia and Herzegovina, Brazil, China, Columbia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

Code Information

all cushions with the following 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.