CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Polaris 5 Spinal System and Polaris 5/Cypher Spinal System recalled
Zimmer Biomet is recalling Polaris 5 Spinal System and Polaris 5/Cypher Spinal System, Thoracolumbosacral pedicle, distributed nationwide in the US. The recall was initiated on 17 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0570-2021
- FDA event ID
- 86762
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2020
- FDA classified
- 15 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 17 Nov 2020 | Recall initiated by company | |
| 15 Dec 2020 | Classified by FDA | +28 days |
| 23 Dec 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Where it was distributed
Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.
Questions about this recall
Is Polaris 5 Spinal System and Polaris 5/Cypher Spinal System, Thoracolumbosacral pedicle recalled?
Yes. Zimmer Biomet recalled Polaris 5 Spinal System and Polaris 5/Cypher Spinal System, Thoracolumbosacral pedicle on 17 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0570-2021.
Why was it 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.
Which lots 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.
Where was it sold?
Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |