NuVasive Recalls 240 Screw Tulip Medical Devices for Disengagement Risk
NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices 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 an implanted medical device that can lead to significant injury or device failure, meeting the criteria for a Severe rating.
Plain-English summary
NuVasive Inc is recalling 240 units of the Screw Tulip, 5.5mm Rod medical device. The recall covers specific batch codes including JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, and JK2400, 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 the device has been implanted in a patient. This defect poses a risk of device failure during or after the surgical procedure.
The affected devices were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. Healthcare providers and patients who have received these specific devices should contact their surgeon or NuVasive Inc for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Screw Tulip , 5.5mm Rod 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 (11)
- Batch: JK1949
- JK2068
- JK2071
- JK2078
- JK2079
- JK2170
- JK2206
- JK2375
- JK2387
- JK2398
- JK2400
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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