Recall Z-2814-2020— Olympus Corporation of the Americas
Class II · Terminated
Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2020-07-14, terminated 2021-09-07. It names one FDA 510(k) clearance: K003214. Product: Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662. Reason: 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.
- Recalling firm
- Olympus Corporation of the Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-14
- Terminated
- 2021-09-07
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.