Smart Stapes Protheses Piston 0.6mm X 4.25 mm recall: Labeling Error
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Why was Smart Stapes Protheses Piston 0.6mm X 4.25 mm 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: PR911937
- Product
- Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 21 units
- Distribution
- CA , FL , GA , PA Foreign: New Zealand , Switzerland
- Recall date
- August 26, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)