Use cautionMedical device recall · FDA · Published November 17, 2020
Zimmer Biomet Polaris 5.5 Spinal System Recall: Risk of Spinal Screw Failure with DC
Zimmer Biomet recalls Polaris 5.5 Spinal Systems due to risk of spinal screw failure when used with direct current stimulation systems. Affected items include specific model numbers and kits sold in the US.
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.
Take action
Contact the company
📍Recalling firmZimmer Biomet, Inc.1800 W Center St · Warsaw, IN 46580-2304
“Zimmer Biomet Polaris 5.5 Spinal System Recall: Risk of Spinal Screw Failure with DC.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63907-zimmer-biomet-polaris-5-5-spinal-system-recall-risk-of. Based on FDA recall #Z-0570-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0570-2021%22&limit=1).
The FDA announced on November 17, 2020, that Zimmer Biomet, Inc. is recalling its Polaris 5.5 Spinal System and related products due to a hazard of construct failure when using Translation Screws with direct current stimulation. The agency classified the recall as Class II.
How to tell if you have it
Brand: Zimmer Biomet
Product: Polaris 5.5 Spinal System
Product: Polaris 5.5/Cypher Spinal System
Product: Thoracolumbosacral pedicle screw system
Affected items: 756 item numbers and three kit part numbers listed in ZFA 2020-00333
Units affected: 57,715 units
The hazard
The recall addresses changes to the contraindications section indicating that Translation Screws should not be used with a direct current stimulation system. This is because a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation systems.
Context
GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since June 5, 2017. Recent similar recalls include the Polaris Spinal System fracture risk recall on November 20, 2020, and the Hip Cup sterilant risk recall on September 24, 2020. Other recent recalls of similar products include the Zimmer Off-Axis Shoulder System guide recall due to plastic guide breakage on May 20, 2026.
How to tell if you have this one
Check for specific item numbers listed in the ZFA 2020-00333 Affected Product List. The recall includes 756 item numbers and three kit part numbers sold in the US.
Brand
Zimmer Biomet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Product List
Check the ZFA 2020-00333 Affected Product List for specific item numbers and kit part numbers to confirm if your device is recalled.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0570-2021 (November 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0570-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.