NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 40mm Cannulated Screw Shanks because the tulip portion may 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving structural defects in medical devices that could lead to significant injury or require hospitalization are rated as Severe (4).
Plain-English summary
NuVasive Inc is recalling 240 units of 7.5mm x 40mm Cannulated Screw Shanks. The recall affects specific batches identified by codes JK2098 and JK2187, with subsequent codes KWP, KWQ, MNH, and MNI. The product was 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 is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received these specific screw shanks should contact NuVasive Inc or their local FDA office for further instructions on removal or replacement. Consumers should not attempt to remove the device themselves.
The recalled product
- Product
- 7.5mm x 40mm 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: JK2098
- JK2187
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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