PALLAS M/MAXIMIS Driver Shaft recall
PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.…
Why was PALLAS M/MAXIMIS Driver Shaft recalled?
Devices are not consistent with Quality System Requirements.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Instrument, Known Lot No. WNV111014.
- Product
- PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL.…
- Recalling firm
- Valorem Surgical LLC
- Quantity
- 262 units total
- Distribution
- Nationwide Distribution - US including CA and VA.
- Recall date
- August 16, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)