Tornier Perform Humeral Nucleus Recall: Bacterial Endotoxin Risk
Tornier recalls a specific lot of Perform Humeral Nucleus implants due to potential bacterial endotoxin levels exceeding safety limits. Affected patients should contact Tornier for guidance.
Lower-risk recall
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Contact the company
What happened, in plain English
Tornier is recalling a specific lot of Perform Humeral Nucle: a shoulder implant component. This recall is due to a risk of bacterial endotoxin levels exceeding safe limits, which could potentially cause infection or other complications during surgery. Read more at govinfonow.com/recall/54148-tornier-perform-humeral-nucleus-recall-bacterial-endotoxin-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/54148-tornier-perform-humeral-nucleus-recall-bacterial-endotoxin-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3155-2024
Cite this page
“Tornier Perform Humeral Nucleus Recall: Bacterial Endotoxin Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54148-tornier-perform-humeral-nucleus-recall-bacterial-endotoxin-risk. Based on FDA recall #Z-3155-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3155-2024%22&limit=1).
Why it’s dangerous
The implant component may contain higher levels of bacterial endotoxins than allowed by safety standards. This could potentially lead to infections or other complications during surgery if the implant is used without proper testing.
Who’s affected
Patients who received the specific lot number 3268BA of the Perform Humeral Nucleus implant during shoulder surgery are affected. Surgeons and medical facilities using this implant are also at risk.
How to tell if you have this one
Check if your implant has the lot number 3268BA and the reference code DWM003A. This specific lot was used in shoulder surgeries by Tornier.
- Brand
Tornier- Category
Medical device
What to do — step by step
Contact Tornier
Reach out to Tornier directly for guidance on next steps regarding your implant.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide distribution in the states of IL, WI, AZ, NV, SD.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Illinois, Nevada, South Dakota, Wisconsin.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-3155-2024 (August 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3155-2024 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.