NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 55mm Cannulated 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 the defect involves a structural failure of an implanted medical device that can lead to significant injury, meeting the criteria for a Severe rating.
Plain-English summary
NuVasive Inc is recalling 240 units of 6.5mm x 55mm Cannulated Screw Shanks. The recall involves specific batch codes JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, and JK2244, 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 implantation. This defect presents a risk of harm to patients who have received these devices.
The affected products were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. Healthcare providers and patients should contact NuVasive Inc for instructions on how to proceed with the recall.
The recalled product
- Product
- 6.5mm x 55mm 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 (9)
- Batch: JK2060
- JK2046
- JK2180
- JK2202
- JK2213
- JK2230
- JK2231
- JK2247
- JK2244
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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