Z-2813-2020 Class II Terminated
FDA device recall Z-2813-2020 was initiated by Olympus Corporation of the Americas on July 14, 2020 and is designated Class II. 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 The recall status is terminated (terminated September 7, 2021). Affected quantity: 16 units.
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