Z-2813-2020Class II

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

Name: Z-2813-2020 Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Creator: Olympus Corporation of the Americas
Published: 2020-07-14
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2020-07-14 / Terminated / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168 on 2020-07-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2813-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-14
Posted: 2020-08-14
Terminated: 2021-09-07
Recalling firm: OLYMPUS Corporation of the Americas
Product: Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Product code: ETB Prosthesis, Partial Ossicular Replacement
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
Root cause tag: packaging
FDA 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 [email protected].
Quantity in commerce: 16 units
Distribution: CA , FL , GA , PA Foreign: New Zealand , Switzerland
Product codes and lots: Lot number: PR898678

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2813-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2813-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14
Z-2814-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-26	2020-08-14

Product code ETB

K003214Class IISmith & Nephew PistonsGyrus Ent LLC / cleared 2000-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)