Tornier recalls Aequalis Ascend Flex humeral stems with specific part numbers due to potential movement in shipping packaging that could transfer PETG material to the stem.
During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the product to rub against the PETG blister shipping container causing the transfer of PETG material from the blister container to the stem.
Tornier is recalling certain Aequalis Ascend Flex humeral stems because they might shift during shipping. This shifting could cause PETG plastic from the packaging to transfer to the stem, which may affect the implant's safety and performance.
During shipping, the humeral stem might move within its packaging. This movement can cause it to rub against the PETG blister container, transferring PETG material to the stem. This transfer could potentially affect the stem's integrity and function in the body.
Orthopedic surgeons and patients who have received the recalled Aequalis Ascend Flex humeral stems with the listed part numbers. Those most at risk are individuals using the stems in shoulder replacement surgeries.
Check the part number on the stem, which includes UDI codes like DWF601A 3700386944475 through DWF719C 3700386945540. The product is used in shoulder replacement surgeries.
Identify the part number on the stem, which includes UDI codes such as DWF601A 3700386944475 through DWF719C 3700386945540.
The affected part numbers include UDI codes from DWF601A 3700386944475 through DWF719C 3700386945540.
During shipping, the humeral stem might move within its packaging, causing PETG material from the blister container to transfer to the stem.
Check the part number on the stem to see if it matches the recalled list. If it does, contact Tornier for further instructions.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-0405-2020 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-0405-2020 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.
