Stryker Instruments Div. of Stryker Corporation recalls System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-steri

Recalled February 18, 2015 · FDA recall Z-1066-2015 · Stryker Instruments Div. of Stryker

Hazard

Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker. · FDA Class II

Units

399

Sold at

Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AR, CA, CO, FL, GA, HI, MD, NC, NY, PA, SC, TX, and VA, and the countries of Australia, Canada, Switzerland, Hong Kong, South Africa, Chile, Korea, Poland, India, Colombia, The Netherlands, and France.

Description

Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.

Product

System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.

Manufacturer(s)

Stryker Instruments Div. of Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →