CLASS II Device recall · Reported 21 Jul 2021 · FDA Enforcement Report
Aequalis Ascend Flex Shoulder System Reversed Platform recalled
Tornier is recalling Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component), distributed in Illinois, Texas. The recall was initiated on 28 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2025-2021
- FDA event ID
- 88004
- Recalling firm
- Tornier, Bloomington, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2021
- FDA classified
- 12 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 May 2021 | Recall initiated by company | |
| 12 Jul 2021 | Classified by FDA | +45 days |
| 21 Jul 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
Where it was distributed
IL and TX Belgium, France and United Kingdom
Questions about this recall
Why was it recalled?
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Which lots are affected?
Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
Where was it sold?
IL and TX Belgium, France and United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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