FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
- Recall number
- Z-2813-2020
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
- Status
- Terminated
- Initiated
- 2020-07-14
- Posted
- not on file
- Terminated
- 2021-09-07
- 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
- Root cause
- Packaging process control
- Action
- Olympus issued Urgent Medical Device Removal Action letter, dated July 14, 2020 via Federal Express stating reason for recall, health risk and action to take: 1.Immediately assess any affected product you have in stock and quarantine any affected product. 2.Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-XXXX and provide your contact information as indicated in the portal. 3. Olympus will issue a credit or replacement for your affected inventory. In addition, if you may have further distributed this product, please identify your customers, notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly at (484)896-5688 from Monday till Friday 8AM ET to 5PM ET or by e-mail at laura.storms@olympus.com.
- Quantity
- 16 units
- Distribution
- CA , FL , GA , PA Foreign: New Zealand , Switzerland
- Lot, serial or model codes
- Lot number: PR898678
- 510(k) numbers
- ["K003214"]
- PMA numbers
- not on file
- Product code
- ETB
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28