Pallas M/maximis I Handle recall
PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal…
Why was Pallas M/maximis I Handle 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?
Catalog No. 0902-1037. Known Lot No. WNV111125, WNV120802, WNV111109.
- Product
- PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal…
- 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)