NuVasive Recalls 5.5mm Cannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
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 structural defect that can lead to harm after implantation, but the source text does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
NuVasive Inc is recalling 240 units of 5.5mm x 35mm Cannulated Screw Shanks. The recall involves specific batch codes JK2051 and JK2154, with subsequent codes KWP, KWQ, MNH, and MNI. The products were distributed nationwide, including in Oregon, Missouri, Florida, Wisconsin, California, and North Carolina.
The recall was initiated because the tulip portion of the screw assembly can disengage from the shank after implantation. This defect presents a risk of harm to patients who have received the device.
Healthcare providers and patients should contact NuVasive Inc for further information regarding the recall and potential corrective actions.
The recalled product
- Product
- 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
- Manufacturer
- NuVasive Inc
- Affected units
- 240
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)
- Batch: JK2051
- JK2154
Distribution
Part of a larger recall action
This product is one of 31 recalled by NuVasive Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 31 products in this recall →Related recalls
Same manufacturer · NuVasive Inc
See all →- ModerateNuVasive Pulse III Multimodality System remote monitoring connection failure
FDA (Devices) · 2023-02-15
- HighSpinal implant insert may fail to disengage from vertebral body device
FDA (Devices) · 2022-12-28
- HighNuVasive Simplify Disc UDI Barcode Contains Incorrect Size Information
FDA (Devices) · 2022-08-03
- ModerateNuvasive NVM5 EMG Module Recalled for Incorrect Component
FDA (Devices) · 2020-07-29
- HighNuVasive MAGEC 2 Spinal Rods Recalled for Actuator Separation
FDA (Devices) · 2020-05-13
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28