Cortera spinal fixation system screws recalled due to manufacturing specification concerns
XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.
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: This Class II medical device recall involves spinal fixation implant screws that may lack structural strength, a high-risk situation for surgical patients. However, no illnesses or injuries have been reported, and the hazard is potential rather than confirmed. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
XTANT Medical Holdings, Inc. is recalling 330 units of Cortera Spinal Fixation System Screws (6.5mm x 45mm, Poly, Solid, model 150100-65045, Lot DNI). These are metallic implant screws used in spinal surgical procedures.
The recalled screws are marked 'DNI' (Do Not Implant) and were not intended for implantation. The screws may not have been manufactured in accordance with the company's released manufacturing specifications. If implanted, they may not have adequate strength or performance, which could potentially compromise the structural integrity of the surgical repair.
The affected screws were distributed nationwide to healthcare facilities in the following states: Illinois, Wisconsin, Florida, Pennsylvania, California, Texas, Michigan, Missouri, Virginia, Ohio, and Massachusetts.
The recalled product
- Product
- Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
- Manufacturer
- XTANT Medical Holdings, Inc
- Category
- Medical Device — Spinal Implant
- Hazard
- manufacturing-defect
- inadequate-strength
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 (2)
- UDI-DI: 00810076563190
- Lot: DNI
Distribution
Distributed nationwide across the United States.
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