FDAClass IINovember 28, 2012

5.5mm x 35mm Cannulated Screw Shank Subsequent Codes recall

5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Why was 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes recalled?

The tulip portion of the screw assembly can disengage from the shank after implantation.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch: JK2051, JK2154

Product
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Recalling firm
NuVasive Inc
Quantity
240 units total
Distribution
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Recall date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls