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MEDICAL DEVICE RECALLMODERATE
Grace Medical Stapes Prosthesis
Grace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
What to do
Check the device labeling and packaging against the affected model number. Contact your healthcare provider if you have concerns regarding a previously implanted device or if you are scheduled for a procedure using this product.
Why it was recalled
Due to incorrect functional length on device labeling.
How to identify it
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification