NuVasive 6.5mm Cannulated Screw Shank Recall for Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
What this means for you
Illness, injury, or structural failure has been reported. 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 and involves a structural defect in a medical device that can lead to significant injury or property damage, meeting the criteria for a Severe rating.
Plain-English summary
NuVasive Inc is recalling 240 units of 6.5mm x 50mm Cannulated Screw Shanks. The affected products include batch codes JK2039, JK2072, and JK2168, as well as subsequent codes KWP, KWQ, MNH, and MNI. The recall is due to a defect where the tulip portion of the screw assembly can disengage from the shank after implantation.
The affected devices were distributed nationwide, including in Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. The U.S. Food and Drug Administration has classified this recall as Class II.
Healthcare providers and patients should contact NuVasive Inc for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- 6.5mm x 50mm 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 (3)
- Batch: JK2039
- JK2072
- JK2168.
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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