Recall Z-1620-2013 — Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
U.S. FDA — Device Enforcement · United States · 2013-05-23 · Class II
⚙AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Reported risk: This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades while being used during surgery.
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.