Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recall
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Why was Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled?
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
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?
There have been 756 item numbers cleared in the US that are included in the recall scope, as listed on the first tab of the attached ZFA 2020-00333 Affected Product List. To date, there have only been products manufactured for a portion of the affected item numbers. In addition, there are three kit part numbers affected as well. The lot specific information is included on the second tab of the attached ZFA 2020- 0333 Affected Product List.
- Product
- Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 57,715 units
- Distribution
- Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.
- Recall date
- December 23, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)