Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Reported: July 21, 2021 Initiated: May 28, 2021 #Z-2025-2021
Product Description
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Reason for Recall
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Details
- Recalling Firm
- Tornier, Inc
- Units Affected
- 20
- Distribution
- IL and TX Belgium, France and United Kingdom
- Location
- Bloomington, MN
Frequently Asked Questions
What product was recalled? ▼
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.. Recalled by Tornier, Inc. Units affected: 20.
Why was this product recalled? ▼
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2025-2021.
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