FDAClass IINovember 28, 2012

Screw Tulip recall

Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

Why was Screw Tulip 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: JK2069, JK2085, JK2102, JK2188, JK2171

Product
Screw Tulip , 6.25mm Rod 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