Reported Dec 23, 2020 · Terminated
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 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 2 item numbers. In addition, there are three kit part numbers affected as well. The 3 lot specific information is included on the second tab of the attached ZFA 2020- 0333 Affected Product List. - Amount recalled
- 57,715 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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