The Recall Desk
SevereFDA (Devices)·Z-0360-2013·Announced 2012-11-28

NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk

NuVasive Inc is recalling 240 units of 6.5mm x 55mm 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 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 6.5mm x 55mm Cannulated Screw Shanks. The recall involves specific batch codes JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, and JK2244, 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 implantation. This defect presents a risk of harm to patients who have received these devices.

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

The recalled product

Product
6.5mm x 55mm 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 (9)

  • Batch: JK2060
  • JK2046
  • JK2180
  • JK2202
  • JK2213
  • JK2230
  • JK2231
  • JK2247
  • JK2244

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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