Biomet Spine Polaris Screw Inserter Recalled for Tip Failure Risk
Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter due to an increased risk of failure at the driver tip during use.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of device failure during a medical procedure, which poses a risk of harm, but the source text does not report any specific injuries, hospitalizations, or deaths.
Plain-English summary
Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter, catalog number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. The recall is due to an increased risk of failure at the driver tip during screw insertion or removal.
The affected units were distributed nationwide, including in the states of Alabama, Indiana, Missouri, Nebraska, Tennessee, and Texas. The specific lot numbers involved are 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613, and 546613-1.
This recall is classified as Class II by the FDA. Healthcare providers and facilities should identify and stop using the affected units. The source text does not specify a consumer action for the general public, as this is a medical device used in clinical settings.
The recalled product
- Product
- Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
- Manufacturer
- Ebi, Llc
- Hazard
- Affected units
- 59
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Catalog Number 14-500178. Lot numbers: 543619
- 543853
- 543853-1
- 543853-2
- 544233
- 544234-1
- 546613 and 546613-1.
Distribution
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