The Recall Desk
SevereFDA (Devices)·Z-0369-2013·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 40mm 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 that can lead to significant injury, meeting the criteria for a Severe rating.

Plain-English summary

NuVasive Inc is recalling 240 units of 4.5mm x 40mm Noncannulated Screw Shanks. The affected product includes subsequent codes KWP, KWQ, MNH, and MNI, and is associated with batch codes JK2036, JK2132, and JK2350. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall was initiated because the tulip portion of the screw assembly can disengage from the shank after implantation. This defect poses a risk of harm to patients who have received the device.

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 local FDA office for instructions on how to proceed with the recall and potential replacement or removal of the device.

The recalled product

Product
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
Category
Medical Device — Orthopedic Implant
Hazard
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: JK2036
  • JK2132
  • JK2350.

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 →

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