RecallRadar

FDA Device recall Z-0373-2013

6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

On 2012-11-28 the FDA classified a Class II recall of 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI by Nuvasive, citing the tulip portion of the screw assembly can disengage from the shank after implantation.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0373-2013
ClassificationClass II
Statusterminated
Initiated2009-01-05
Published2012-11-28
Last updated2026-09-13 11:53 UTC
CompanyNuvasive
DistributionUS

Product

6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

Reason

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

Identifiers

code_infoBatch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0373-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.