Olympus Corporation of the Americas: Medical Device Recall in 2020 - (Recall #: Z-2813-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 14, 2020

Date Posted: August 26, 2020

Recall Number: Z-2813-2020

Event ID: 86045

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

Status: Terminated

Product Quantity: 16 units

Code Information:

Lot number: PR898678

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated