NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 55mm Cannulated 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 cause harm after implantation, but the source text does not report specific 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 7.5mm x 55mm Cannulated Screw Shanks. The recall affects specific batch codes JK2101 and JK2163, 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 it has been implanted in a patient. This defect presents a risk of harm to the patient.
The affected 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 devices.
The recalled product
- Product
- 7.5mm x 55mm 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: JK2101
- JK2163
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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