Device 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.
Z-1066-2015
Product summary
- Event
- Event 70298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 399
- Official record key
device-enforcement:Z-1066-2015
Official wording
Reason: 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.
Code information: Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.