Severe FDA (Devices)·Z-0368-2013·Announced 2012-11-28

NuVasive Recalls 4.5mm Noncannulated Screw Shanks Due to Disengagement Risk

NuVasive Inc is recalling 240 units of 4.5mm x 35mm Noncannulated 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, which aligns with the rubric criteria for a Severe rating.

Plain-English summary

NuVasive Inc is recalling 240 units of 4.5mm x 35mm Noncannulated Screw Shanks. The affected product includes subsequent codes KWP, KWQ, MNH, and MNI, and is associated with batch codes JK2035, JK2131, and JK2349.

The recall is being conducted because the tulip portion of the screw assembly can disengage from the shank after implantation. This defect poses a risk to patients who have received these specific medical devices.

The affected units were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. Healthcare providers and patients should contact NuVasive Inc or their healthcare provider for instructions on how to proceed with the recall.

The recalled product

Product: 4.5mm x 35mm Noncannulated 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 (3)

Batch: JK2035
JK2131
JK2349

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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