The Recall Desk
HighFDA (Devices)·Z-0356-2013·Announced 2012-11-28

NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

NuVasive Inc is recalling 240 units of 6.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect that poses a risk of harm (disengagement after implantation), but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

NuVasive Inc is recalling 240 units of 6.5mm x 35mm Cannulated Screw Shanks. The affected products are identified by batch codes JK2083 and JK2184, with 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 recalled devices 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. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

Healthcare providers and patients who have received these specific screw shanks should contact NuVasive Inc or their medical provider for instructions on how to proceed. Consumers should not attempt to remove or adjust the device themselves.

The recalled product

Product
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Manufacturer
NuVasive Inc
Category
Medical Device — Orthopedic Implants
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 (2)

  • Batch: JK2083
  • JK2184

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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