NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 30mm 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 agency classification is Class II, and the defect involves a structural failure of an implanted medical device, which aligns with the rubric criteria for Severe severity involving significant injury risk or structural defects.
Plain-English summary
NuVasive Inc is recalling 240 units of 5.5mm x 30mm Cannulated Screw Shanks. The affected products are identified by Batch JK2053 and subsequent codes KWP, KWQ, MNH, and MNI.
The recall is being issued 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 medical devices.
The 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 affected devices.
The recalled product
- Product
- 5.5mm x 30mm 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 (1)
- Batch: JK2053
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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