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FDAJuly 14, 2020device

Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

What to do

FDA enforcement status: Terminated

Brands named

olympus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168 — Recall Details · AllClear