Shoulder prosthesis component distributed with incorrect thickness due to lot swap
Two lots of Aequalis Ascend Flex Shoulder System Reversed Tray components were swapped during distribution, resulting in packages containing components with incorrect thickness.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prosthesis component with confirmed structural variance due to lot swap. No illnesses or injuries reported. This is a risk-of-harm medical device where the defect has occurred but patient harm has not been documented.
Plain-English summary
Tornier, Inc is recalling certain lots of the Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component), a surgical prosthesis component used in shoulder replacement procedures.
During distribution, two lots were swapped, meaning packages contain the incorrect product. The component received may have different thickness than intended, which could affect fit and performance.
The affected lots are Item Number DWF500 Lot 1179AW (Exp. 2026-02-24) and Item Number DWF510 Lot 1197AW (Exp. 2026-02-25). Distribution was limited to facilities in Illinois, Texas, Belgium, France, and the United Kingdom.
Patients who received this implant or healthcare providers with these components in inventory should contact Tornier, Inc for instructions. No illnesses or injuries related to this recall have been reported to the FDA.
The recalled product
- Product
- Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.
- Manufacturer
- Tornier, Inc
- Affected units
- 20
Distribution
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