FDA recall Z-2813-2020

Olympus Corporation of the Americas · Class II · device

Product

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

Reason for recall

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

Distribution

CA , FL , GA , PA Foreign: New Zealand , Switzerland

Key facts

Status: Terminated
Initiation date: 2020-07-14
Report date: 2020-08-26
Termination date: 2021-09-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2813-2020