Z-3007-2017 Class II Terminated
FDA device recall Z-3007-2017 was initiated by Valorem Surgical LLC on Jun 21, 2017 and is designated Class II. Reason for recall: Devices are not consistent with Quality System Requirements. The recall status is terminated (terminated Nov 27, 2018). Affected quantity: 262 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 16, 2017
- Initiation Date
- Jun 21, 2017
- Termination Date
- Nov 27, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 262 units total
Product Description
PALLAS M/MAXIMIS Head Holder. 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 Pattern
Nationwide Distribution - US including CA and VA.
Code Information
Instrument, Known Lot No. WNV110826.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3007-2017
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026