Home / Recalls / Olympus Corporation of the Americas / Z-2813-2020

Z-2813-2020 Class II Terminated

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
August 26, 2020
Initiation Date
July 14, 2020
Termination Date
September 7, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 units

Product Description

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 Pattern

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

Code Information

Lot number: PR898678

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