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Terminated

Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA

FDA Recall Z-0138-2008 · Posted 2007-12-19

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeMJO
Date Initiated2007-09-04
Date Terminated2008-11-03
Product Quantity196 units

Reason for Recall

Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

Firm Action

The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.

Root Cause

Device Design

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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