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.
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: 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
- Affected units
- 330
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
Related recalls
Same manufacturer · XTANT Medical Holdings, Inc
See all →- ModeratenanOss 3D Bone Graft Substitute Incorrectly Labeled with Five-Year Shelf Life
FDA (Devices) · 2026-04-29
- HighXtant pedicle screws mislabeled with an incorrect shorter screw length
FDA (Devices) · 2026-04-15
- HighIrix-A Lumbar Fusion Implants Recalled for Incorrect Expiration Dates
FDA (Devices) · 2025-02-26
- HighCortera Spinal Fixation System screws recalled for incorrect dimensions
FDA (Devices) · 2024-02-07
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighCortera Spinal Fixation System screws recalled for incorrect dimensions
FDA (Devices) · 2024-02-07
- HighSpinal fixation screws recalled for not meeting performance standards
FDA (Devices) · 2025-11-19
- ModerateSynthes 4.5 mm Cortex Screw Recalled for Labeling Mismatch
FDA (Devices) · 2016-07-20
- ModerateCustom Spine ISSYS LP Inverted Screw System Recall for Dimensional Defect
FDA (Devices) · 2013-08-07
- HighSpinal Implant Screws Recalled for Defective Titanium Material
FDA (Devices) · 2023-04-26
- HighSpinal fixation screws recalled for reduced titanium gripping strength
FDA (Devices) · 2023-04-26