Tornier recalls specific lots of Aequalis Ascend Flex Shoulder System Reversed Tray components due to incorrect thickness. Affected patients should contact Tornier for guidance.
“Tornier Aequalis Ascend Flex Shoulder System: Incorrect Component Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62449-tornier-aequalis-ascend-flex-shoulder-system-incorrect-component-risk. Based on FDA recall #Z-2025-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2025-2021%22&limit=1).
The FDA announced on May 28, 2021, that Tornier, Inc. recalled the Aequalis Ascend Flex Shoulder System Reversed Platform because two lots were swapped, resulting in incorrect product packaging and potentially different component thickness. This voluntary Class II recall affects 20 units distributed in Illinois, Texas, Belgium, France, and the United Kingdom.
Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24
Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
The hazard
Two lots have been swapped, placing the incorrect product in the package. The component may be of a different thickness than intended.
Context
GovInfoNow's records show Tornier, Inc. has 12 other recalls on record since February 8, 2018. Other recent recalls include the Tornier HRS Max Parts Recall (March 5, 2026), the Tornier Perip Screw Recall (December 19, 2025), and the Tornier Latitude EV Humeral Revision Stem Trial Recall (March 3, 2025). Other recent recalls of similar products include the U2 Total Knee System recall (May 20, 2026), the restor3d Veritas Standard Glenoid Baseplate Recall (June 30, 2026), and the U2 Total Knee System Femoral Valgus Adaptor Recall (May 20, 2026).
How to tell if you have this one
Check for item numbers DWF500 or DWF510 with lot numbers 1179AW or 1197AW. These components were sold as sterile surgical implants for shoulder replacements.
Brand
Tornier
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Tornier
Reach out to Tornier directly to confirm if your specific component is affected and get guidance on next steps.
Where it went and when
Where it was distributed
Distributed in Illinois and Texas, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “IL and TX Belgium, France and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Texas.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2025-2021 (May 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2025-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.