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

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only — recall Z-0566-2018

U.S. FDA — Device Enforcement · United States · 2017-12-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0566-2018
Date of alert
2017-12-22
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)
00643169363502
Reported risk: Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
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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