Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703

FDA device recall Z-1266-2014 · posted 2014-03-21 · Terminated

Recall details

Recalling firm

Bock,Otto,Orthopedic Ind,Inc

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.

Action taken

An Urgent Voluntary Device Recall letter was sent to customers beginning 1/31/2014. The letter identified the affected material numbers, described the reason for recall, and asked that product be returned or destroyed. A response Questionnaire was asked to be completed and returned.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

IMP

Quantity affected

464 units (US 113, OUS 351)

Distribution

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

Date initiated

2014-01-31

Date posted

2014-03-21

Date terminated

2018-05-07

Location

Minneapolis, MN