FDAFDA · Food and drugs·Recall number Z-1066-2015
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.
Published February 18, 2015 · Recall initiated: January 7, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- 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.
- Lot
- Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.