Z-1066-2015 Class II Terminated
FDA device recall Z-1066-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jan 7, 2015 and is designated Class II. 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. The recall status is terminated (terminated Mar 9, 2016). Affected quantity: 399.
Recall details
- Product Type
- Devices
- Report Date
- Feb 18, 2015
- Initiation Date
- Jan 7, 2015
- Termination Date
- Mar 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 399
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.
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.
Code information
Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1066-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026