Reported Jul 21, 2021 · Terminated
Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier…
Tornier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109
Is this the product you have?
- Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
- Lot codes and dates
- Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25
- Amount recalled
- 20
Where it was sold
Why it was recalled
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
This product could cause temporary or reversible health problems — stop using it.
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