FDA recall Z-2934-2017

Product

PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Reason for recall

Devices are not consistent with Quality System Requirements.

Distribution

Nationwide Distribution - US including CA and VA.

Key facts

Status

Terminated

Initiation date

2017-06-21

Report date

2017-08-16

Termination date

2018-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2934-2017