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Terminated

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.

FDA Recall Z-0866-2014 · Posted 2014-01-30

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeHXX
Date Initiated2014-01-03
Date Terminated2014-05-16
Product Quantity7 units

Reason for Recall

The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.

Firm Action

The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.

Root Cause

Reprocessing Controls

Distribution Pattern

US Distribution in the states of CA, NC, TX, IN, NJ, and MI.

Official Source

View FDA Recall →

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

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