Z-0047-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2017
- Initiation Date
- September 18, 2017
- Termination Date
- December 11, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 devices
Product Description
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
Reason for Recall
The torque wrench used to tighten system bolts during installation was found to be out of tolerance
Distribution Pattern
Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.
Code Information
Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.