Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
Zimmer Biomet is updating instructions for Polaris and Cypher spinal screws to warn against using them with direct current stimulation due to construct failure risks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a Class II labeling correction to update contraindications regarding construct failure risk. No injuries or illnesses are reported, and the hazard is theoretical until the specific contraindicated use occurs.
Plain-English summary
Zimmer Biomet, Inc. is conducting a medical device correction for the Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, specifically the Thoracolumbosacral pedicle screw system. The recall involves 57,715 units distributed domestically across the United States. The correction is necessary to update the Instructions for Use (IFU) and Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System.
The update adds a contraindication stating that Translation Screws should not be used with direct current stimulation. The source text indicates that a high probability of construct failure exists when using Translation Screws containing CoCr (Cobalt-Chromium) with direct current stimulation systems. This contraindication applies to US customers, as direct stimulation devices are only available in the US.
Healthcare providers and users should review the updated Instructions for Use and Surgical Techniques. The recall scope includes 756 item numbers cleared in the US, as well as three kit part numbers. Specific lot information is available in the attached Affected Product List (ZFA 2020-00333). Users should ensure they are not using the affected screws in conjunction with direct current stimulation systems.
The recalled product
- Product
- Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 57,715
Distribution
Distributed nationwide across the United States.
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