FDA recall Z-0047-2018

Product

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

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.

Key facts

Status

Terminated

Initiation date

2017-09-18

Report date

2017-11-01

Termination date

2017-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hoffman Estates, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2018