NuVasive Recalls 6.5mm Noncannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, meeting the criteria for a Severe rating.
Plain-English summary
NuVasive Inc is voluntarily recalling 240 units of 6.5mm x 50mm Noncannulated Screw Shanks. The recall is due to a defect where the tulip portion of the screw assembly can disengage from the shank after the device has been implanted in a patient.
The affected products were distributed nationwide, including in Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. The specific batch codes associated with this recall are 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, and JK2183. Subsequent codes KWP, KWQ, MNH, and MNI are also listed in the product description.
Healthcare providers and patients should contact NuVasive Inc for further instructions regarding the removal or replacement of these devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 6.5mm x 50mm Noncannulated 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 (10)
- Batch: 2008400621
- JK2039
- JK2141
- JK2191
- JK2177
- JK2178
- JK2179
- JK2181
- JK2182
- JK2183
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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