Biomet Spine Recalls Polaris Translation Screws Due to Head Dissociation
Biomet Spine is recalling 7,092 Polaris Translation Screws because the screw head may separate from the shaft. The recall covers nationwide distribution including Puerto Rico.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a structural failure (dissociation) of a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biomet Spine is recalling 7,092 units of the Polaris 5.5 TI Spinal System Translation Screws. The recall is due to reports of the screw head dissociating from the shaft. The affected screws are intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system.
The recall covers nationwide distribution, including Puerto Rico. The firm expects all Translation Screw Systems containing a cobalt chrome component that were used and contacted with the SpF Implantable Spine Fusion Stimulator to be at risk for this failure mode. Multiple item and lot numbers are involved.
Healthcare providers should stop using the affected devices and contact Biomet Spine for further instructions. Patients who have had these devices implanted should consult their healthcare provider regarding the reported failure mode.
The recalled product
- Product
- BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
- Manufacturer
- Ebi, Llc
- Hazard
- Affected units
- 7,092
Distribution
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