Tornier recalls specific lots of Aequalis Ascend Flex Shoulder System Reversed Tray components due to incorrect thickness. Affected patients should contact Tornier for guidance.
Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
Tornier is recalling two specific lots of Aequalis Ascend Flex Shoulder System Reversed Tray components because they contain the wrong thickness. This could lead to improper fitting and potential complications after surgery.
The recalled components have incorrect thickness due to a swap between two lots. This could result in improper fitting during surgery, potentially causing complications like instability or improper joint movement.
Patients who received the recalled lots (DWF500 Lot #1179AW or DWF510 Lot #1197AW) for shoulder replacement surgery. Surgeons and medical staff handling these components are also at risk.
Check for item numbers DWF500 or DWF510 with lot numbers 1179AW or 1197AW. These components were sold as sterile surgical implants for shoulder replacements.
Reach out to Tornier directly to confirm if your specific component is affected and get guidance on next steps.
Two lots were swapped, resulting in components of incorrect thickness that could lead to improper fitting during surgery.
Look for item numbers DWF500 or DWF510 with lot numbers 1179AW or 1197AW on the packaging.
The recall does not require immediate discontinuation; contact Tornier for specific guidance based on your case.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-2025-2021 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-2025-2021 from Tornier. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
