FDA recall Z-0644-2018

Product

Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine:

Reason for recall

Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage.

Distribution

United States

Key facts

Status

Terminated

Initiation date

2018-01-08

Report date

2018-02-28

Termination date

2018-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0644-2018