Product Wiki · Recalls · U.S. FDA — Device Enforcement

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument. — recall Z-0866-2014

U.S. FDA — Device Enforcement · United States · 2014-01-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0866-2014
Date of alert
2014-01-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Sofamor Danek USA Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
9010000820
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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