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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86762

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Z-0570-2021
Recall number
Z-0570-2021
Initiated
November 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
57,715 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

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Inspect official wording and provenance

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.

Code information

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.

Distribution pattern

Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.