Bock,Otto,Orthopedic Ind,Inc: Medical Device Recall in 2014 - (Recall #: Z-1266-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 31, 2014

Date Posted: March 26, 2014

Recall Number: Z-1266-2014

Event ID: 67576

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.

Status: Terminated

Product Quantity: 464 units (US 113, OUS 351)

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated