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

Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The — recall Z-3058-2017

U.S. FDA — Device Enforcement · United States · 2017-06-29 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3058-2017
Date of alert: 2017-06-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Navigation, Inc.
Product category: device
Product type: Devices

Reported risk: The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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