FDA-Device2020-08-26Class II
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Olympus Corporation of the Americas
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
Sold states
CA , FL , GA , PA Foreign: New Zealand , Switzerland
Affected count
21 units
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2814-2020Don't want to check this manually?
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