NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 50mm 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 recall is classified as FDA Class II and involves a structural defect in a medical device that can lead to significant injury, meeting the criteria for a Severe rating.
Plain-English summary
NuVasive Inc is voluntarily recalling 240 units of 7.5mm x 50mm Cannulated Screw Shanks. The affected products are identified by batch codes JK2056, JK2100, and JK2162, with 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.
The recalled devices were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received these specific screw shanks should contact NuVasive Inc or their healthcare provider for instructions on how to proceed. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- 7.5mm x 50mm 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 (3)
- Batch: JK2056
- JK2100
- JK2162
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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