Tornier Aequalis Ascend Flex Humeral Stem Recall: Shipping Packaging Risk
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/66779-tornier-aequalis-ascend-flex-humeral-stem-recall-shipping-packaging-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/66779-tornier-aequalis-ascend-flex-humeral-stem-recall-shipping-packaging-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0405-2020
Cite this page
“Tornier Aequalis Ascend Flex Humeral Stem Recall: Shipping Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66779-tornier-aequalis-ascend-flex-humeral-stem-recall-shipping-packaging-risk. Based on FDA recall #Z-0405-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Tornier- Category
Medical device
What to do — step by step
Check Product Part Number
Identify the part number on the stem, which includes UDI codes such as DWF601A 3700386944475 through DWF719C 3700386945540.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Check the part number on the stem to see if it matches the recalled list. If it does, contact Tornier for further instructions.
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Where this comes from
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.
- Official source: FDA Recall #Z-0405-2020 (October 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0405-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.