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.
Reported: February 18, 2015 Initiated: January 7, 2015 #Z-1066-2015
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 399
- Distribution
- 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.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 399.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1066-2015.
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