CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recalled
NuVasive is recalling Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI, distributed nationwide in the US. The recall was initiated on 5 Jan 2009 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0375-2013
- FDA event ID
- 52634
- Recalling firm
- NuVasive, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2009
- FDA classified
- 19 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 5 Jan 2009 | Recall initiated by company | |
| 19 Nov 2012 | Classified by FDA | +1414 days |
| 28 Nov 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The tulip portion of the screw assembly can disengage from the shank after implantation.
Product as listed by the FDA
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Where it was distributed
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
Questions about this recall
Is Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI recalled?
Yes. NuVasive recalled Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI on 5 Jan 2009. The recall is Class II and its status is Terminated. Recall number Z-0375-2013.
Why was it recalled?
The tulip portion of the screw assembly can disengage from the shank after implantation.
Which lots are affected?
Batch: 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, JK2183, JK2141, JK2181
Where was it sold?
Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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