NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
What this means for you
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 can lead to injury, but the source text does not report specific illnesses, injuries, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
NuVasive Inc is recalling 240 units of 5.5mm x 40mm Noncannulated Screw Shanks. The affected products include batch codes JK2037, JK2130, and JK2366, 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 presents a risk of harm 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 on how to proceed with the recall.
The recalled product
- Product
- 5.5mm x 40mm 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 (4)
- Batch: JK2037
- JK2130
- JK2037
- JK2366
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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