NuVasive Recalls 240 Screw Tulip Implants Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.25mm Screw Tulip implants 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 the defect involves a structural failure of an implanted medical device, which aligns with the 'Severe' criteria for significant injury or structural defects.
Plain-English summary
NuVasive Inc is recalling 240 units of the 6.25mm Screw Tulip implant. The recall covers specific batch codes JK2069, JK2085, JK2102, JK2188, and JK2171, 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 poses a risk of device failure within the body.
The affected products were distributed nationwide, including in Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. Healthcare providers and patients should contact NuVasive Inc or their local FDA office for instructions on how to proceed with the recall and any necessary medical follow-up.
The recalled product
- Product
- Screw Tulip , 6.25mm 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 (5)
- Batch: JK2069
- JK2085
- JK2102
- JK2188
- JK2171
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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