Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Reported: August 26, 2020 Initiated: July 14, 2020 #Z-2814-2020
Product Description
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
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
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 21 units
- Distribution
- CA , FL , GA , PA Foreign: New Zealand , Switzerland
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662. Recalled by Olympus Corporation of the Americas. Units affected: 21 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2020. Severity: Moderate. Recall number: Z-2814-2020.
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