Recall Z-2878-2017— Valorem Surgical LLC
Class II · Terminated
Class II FDA medical device recall by Valorem Surgical LLC, initiated 2017-06-21, terminated 2018-11-27. It names one FDA 510(k) clearance: K140359. Product: PALLAS M/MAXIMIS Large Crosslink. 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: Devices are not consistent with Quality System Requirements..
- Recalling firm
- Valorem Surgical LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-21
- Terminated
- 2018-11-27
- Firm location
- Chicago, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PALLAS M/MAXIMIS Large Crosslink. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.