FDA recall Z-0597-2018

Product

Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation

Reason for recall

The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-08-03

Report date

2018-02-21

Termination date

2019-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0597-2018