The Recall Desk
SevereFDA (Devices)·Z-0351-2013·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 40mm 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 involves a structural defect in an implanted medical device that can disengage, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury or structural defect).

Plain-English summary

NuVasive Inc is recalling 240 units of 5.5mm x 40mm Cannulated Screw Shanks. The affected product includes batch codes JK2042, JK2080, and JK2151, 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 it has been implanted in a patient.

The affected units were distributed nationwide, including in the states of Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. This recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients who have received these specific screw shanks should contact NuVasive Inc or their medical provider for further instructions on how to proceed. The source text does not specify a particular action for consumers to take other than the general recall notification.

The recalled product

Product
5.5mm x 40mm Cannulated 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: JK2042
  • JK2080
  • JK2151

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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