PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. 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.
Reported: August 16, 2017 Initiated: June 21, 2017 #Z-2913-2017
Product Description
PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. 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.
Details
- Recalling Firm
- Valorem Surgical LLC
- Units Affected
- 2,225 units total
- Distribution
- Nationwide Distribution - US including CA and VA.
- Location
- Chicago, IL
Frequently Asked Questions
What product was recalled? ▼
PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. 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.. Recalled by Valorem Surgical LLC. Units affected: 2,225 units total.
Why was this product recalled? ▼
Devices are not consistent with Quality System Requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 16, 2017. Severity: Moderate. Recall number: Z-2913-2017.
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