FDA Device recall Z-2813-2020
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
- FDA Device
- Class II
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class II recall of Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168 by Olympus, citing 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; s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2813-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-14 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Olympus |
| Distribution | CA, FL, GA, PA |
Product
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
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
Identifiers
| code_info | Lot number: PR898678 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2813-2020%22
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