SeaSpine Recalls UCR 3mm Hex Large Axial Driver Due to Tip Deformation
SeaSpine Inc is recalling seven units of the UCR 3mm Hex, Large Axial Driver because the tip may twist or become rounded during use.
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 surgical instrument with a mechanical defect that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
SeaSpine Inc is recalling seven units of the Integra UCR 3mm Hex, Large Axial Driver (Catalogue Number 91-1123, Lot No. M016090B). The recall was initiated after an investigation of complaints identified a potential for the tip of the instrument to twist or become rounded during use.
The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws provided with the Malibu, UCR, and NewPort Systems. These systems are intended for use as temporary or permanent posterior, non-cervical implants to correct spinal disorders and provide stabilization of the spine. The affected units were distributed in the United States, specifically in the states of Alabama, California, Ohio, New Mexico, and Tennessee.
Healthcare facilities and consumers who possess this specific lot of the UCR 3mm Hex, Large Axial Driver should stop using the instrument and contact SeaSpine Inc for instructions on return or replacement.
The recalled product
- Product
- Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used…
- Manufacturer
- SeaSpine Inc
- Hazard
- Affected units
- 7
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 (1)
- Catalogue Number: 91- 1123. Lot No. M016090B.
Distribution
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