Recall Z-2813-2020 ยท ETB Prosthesis, Partial Ossicular Replacement
Olympus Corporation of the Americas
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
| Date | Jul 14, 2020 |
| Status | Terminated |
| 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 |
| Quantity | 16 units |
| Distribution | CA , FL , GA , PA Foreign: New Zealand , Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003214 | SMITH & NEPHEW PISTONS Gyrus Ent LLC, Oct 31, 2000 |