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.
Zimmer Biomet is recalling certain spinal screw systems that could fail if used with direct current stimulation devices. This risk could lead to spinal instability or injury during surgery.
The spinal screws contain cobalt-chromium alloy that can cause structural failure when used with direct current stimulation systems during surgery. This risk leads to potential spinal instability or injury.
Surgical teams using the Polaris 5.5 Spinal System or Polaris 5.5/Cypher Spinal System for spinal procedures are most at risk. Patients undergoing surgery with these systems may be affected.
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.
Check the ZFA 2020-00333 Affected Product List for specific item numbers and kit part numbers to confirm if your device is recalled.
Zimmer Biomet updated the Instructions for Use to warn that cobalt-chromium spinal screws can fail when used with direct current stimulation systems during surgery.
Check the ZFA 2020-00333 Affected Product List for specific item numbers and kit part numbers that were sold in the US.
The recall does not require immediate action; review the product list to confirm if your device is affected.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0570-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0570-2021 from Zimmer Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
