NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 45mm Noncannulated 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 is classified as FDA Class II, and the hazard involves a structural defect in an implanted medical device that can lead to harm, fitting the criteria for a risk-of-harm product where injury has not yet been explicitly reported in the source text.
Plain-English summary
NuVasive Inc is recalling 240 units of 6.5mm x 45mm Noncannulated Screw Shanks. The recall affects specific batch codes including JK2045, JK2038, JK2140, JK2361, JK2362, JK2365, JK2368, JK2370, JK2369, JK2377, and JK2379, as well as subsequent codes KWP, KWQ, MNH, and MNI.
The recall was initiated because the tulip portion of the screw assembly can disengage from the shank after implantation. This defect poses a risk to patients who have received these specific medical devices.
The affected products were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. Healthcare providers and patients should contact NuVasive Inc for further instructions regarding the recall and potential replacement or removal of the devices.
The recalled product
- Product
- 6.5mm x 45mm Noncannulated 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 (11)
- Batch: JK2045
- JK2038
- JK2140
- JK2361
- JK2362
- JK2365
- JK2368
- JK2370
- JK2369
- JK2377
- JK2379
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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