The Recall Desk
SevereFDA (Devices)·Z-0375-2013·Announced 2012-11-28

NuVasive Recalls 6.5mm Noncannulated Screw Shank Due to Disengagement Risk

NuVasive Inc is recalling 240 units of 6.5mm x 50mm 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 involves a structural defect in an implanted medical device that can lead to significant injury, meeting the criteria for a Severe rating.

Plain-English summary

NuVasive Inc is voluntarily recalling 240 units of 6.5mm x 50mm Noncannulated Screw Shanks. The recall is due to a defect where the tulip portion of the screw assembly can disengage from the shank after the device has been implanted in a patient.

The affected products were distributed nationwide, including in Oregon, Missouri, Florida, Wisconsin, California, and North Carolina. The specific batch codes associated with this recall are 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, and JK2183. Subsequent codes KWP, KWQ, MNH, and MNI are also listed in the product description.

Healthcare providers and patients should contact NuVasive Inc for further instructions regarding the removal or replacement of these devices. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
6.5mm x 50mm 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 (10)

  • Batch: 2008400621
  • JK2039
  • JK2141
  • JK2191
  • JK2177
  • JK2178
  • JK2179
  • JK2181
  • JK2182
  • JK2183

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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