Severe FDA (Devices)·Z-0352-2013·Announced 2012-11-28

NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk

NuVasive Inc is recalling 240 units of 5.5mm x 45mm 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 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 5.5mm x 45mm Cannulated Screw Shanks. The affected products are identified by batch codes JK2058, JK2054, JK2081, and JK2143, with subsequent codes KWP, KWQ, MNH, and MNI.

The recall is issued 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 medical devices.

The 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 further instructions regarding the removal or replacement of these devices.

The recalled product

Product: 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer: NuVasive Inc
Category: Medical Device — Orthopedic Implant
Hazard: structural-failure
implant-disengagement
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 (4)

Batch: JK2058
JK2054
JK2081
JK2143

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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.

See all 31 products in this recall →

Same manufacturer · NuVasive Inc

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