Medtronic ZEVO Anterior Cervical Plate System Slot Screw Recall
Medtronic is recalling 39 ZEVO Anterior Cervical Plate System slot screws because they are 15mm long instead of the specified 17mm.
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 involves a medical device with a dimensional defect that could affect spinal fixation, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 39 units of the ZEVO Anterior Cervical Plate System Slot Screw, Reference 7710015, Size 4.5mm x 15mm. The recall is due to a manufacturing defect where the screws have an overall length of 15mm, whereas the specification requires an overall length of approximately 17mm.
The affected products were distributed worldwide, including in the United States (specifically in Georgia, Connecticut, Louisiana, Maryland, Wyoming, Indiana, and Florida) and France. The specific lot number for the recalled items is H5399679, and the GTIN/UPN is 643169329218.
Healthcare providers and patients should check their inventory and medical records for this specific product reference and lot number. If the product is found, it should be removed from use and returned to Medtronic Sofamor Danek USA Inc according to their instructions.
The recalled product
- Product
- Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Fixation
- Affected units
- 39
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)
- GTIN/UPN: 643169329218 Lot Number: H5399679
Distribution
Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- HighGrafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
FDA (Devices) · 2023-11-01
- HighGrafton Plus DBM Paste medical device recalled for packaging inspection failure
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
- HighGrafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
FDA (Devices) · 2023-11-01
Same hazard · dimensional defect
See all →- HighMedline ENFit G-tube connectors may leak from dimensional specification failure
FDA (Devices) · 2026-04-08
- HighMedline ENFit G-tube connector kits may leak from dimensional defect
FDA (Devices) · 2026-04-08
- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- ModerateMedline Soft Liner Dimensional Variation May Affect Outer Canister Fit
FDA (Devices) · 2024-08-28
- ModerateMedical Device Liner Recalled for Dimensional Variation Affecting Fit
FDA (Devices) · 2024-08-28