NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 30mm Cannulated Screw Shanks because the tulip portion may 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 property damage, meeting the criteria for a Severe rating.
Plain-English summary
NuVasive Inc is recalling 240 units of 6.5mm x 30mm Cannulated Screw Shanks. The affected products are identified by batch codes JK2057 and JK2157, with subsequent codes KWP, KWQ, MNH, and MNI. The recall is due to a defect where the tulip portion of the screw assembly can disengage from the shank after it has been implanted in a patient.
The affected units were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and patients should contact NuVasive Inc for further instructions regarding the removal or replacement of these devices. Consumers should not attempt to remove the device themselves and should consult their healthcare provider if they have had this specific product implanted.
The recalled product
- Product
- 6.5mm x 30mm 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: JK2057
- JK2157.
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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