medical Class II Updated 2020-08-26

Olympus Corporation of the Americas recalls Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossi

Recalled Product

Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662


Hazard / Issue

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

Issued by

FDA

Affected States: CA, FL, GA, PA
Lot/Code Info: Lot number: PR911937
View official government recall

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