CLASS II Device recall · Reported 26 Aug 2020 · FDA Enforcement Report

Smart Stapes Protheses Piston- Partial Ossicular Replacement recalled

Olympus Corporation of the Americas is recalling Smart Stapes Protheses Piston- Partial Ossicular Replacement, distributed in California, Florida, Georgia, Pennsylvania. The recall was initiated on 14 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: PR911937

Quantity recalled21 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2814-2020
FDA event ID: 86045
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Jul 2020
FDA classified: 14 Aug 2020
Reported: 26 Aug 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

14 Jul 2020	Recall initiated by company
14 Aug 2020	Classified by FDA	+31 days
26 Aug 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662

Where it was distributed

CA , FL , GA , PA Foreign: New Zealand , Switzerland

California Florida Georgia Pennsylvania

Questions about this recall

Is Smart Stapes Protheses Piston- Partial Ossicular Replacement recalled?

Yes. Olympus Corporation of the Americas recalled Smart Stapes Protheses Piston- Partial Ossicular Replacement on 14 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2814-2020.

Why was it recalled?

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

Which lots are affected?

Lot number: PR911937

Where was it sold?

CA , FL , GA , PA Foreign: New Zealand , Switzerland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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