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.
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 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.
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