—#182561

Product

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

FDA product code: ETB — Prosthesis, Partial Ossicular Replacement
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K003214
Affected lot / code info: Lot number: PR898678

Why it was 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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

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

Timeline

Recall initiated: 2020-07-14
Terminated: 2021-09-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182561. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.