NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm 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 poses a risk of harm (disengagement after implantation), but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
NuVasive Inc is recalling 240 units of 6.5mm x 35mm Cannulated Screw Shanks. The affected products are identified by batch codes JK2083 and JK2184, with 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 it has been implanted in a patient.
The recalled devices were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. This recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare providers and patients who have received these specific screw shanks should contact NuVasive Inc or their medical provider for instructions on how to proceed. Consumers should not attempt to remove or adjust the device themselves.
The recalled product
- Product
- 6.5mm 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: JK2083
- JK2184
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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