Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier
Summary
The FDA issued a Class II for Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) by Tornier, Inc. Reason: Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness..
Details
Source
Device Recall
External ID
Z-2025-2021
Action Date
2021-07-21
Status
Terminated
Category
device
Product Description
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Lot/Code Info: Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
Quantity Affected: 20
Reason for Recall
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Distribution
IL and TX Belgium, France and United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-28
Company
Bloomington, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tornier, Inc has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tornier, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tornier, Inc have FDA actions?
Tornier, Inc has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2025-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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