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Terminated

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

FDA Recall Z-1941-2020 · Posted None

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeKWP
Date Initiated2020-03-26
Date Terminated2021-03-26
Product Quantity83 units.

Reason for Recall

Nonconforming product; length of the product measured shorter than the labeled length.

Firm Action

Medtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution in the states of CA and MI.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081297VERTEX RECONSTRUCTION SYSTEMMedtronic Sofamor Danek · 2008-06-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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