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.
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
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.
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.
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.
Check if your implant has the lot number 3268BA and the reference code DWM003A. This specific lot was used in shoulder surgeries by Tornier.
Reach out to Tornier directly for guidance on next steps regarding your implant.
The recall indicates a potential risk of bacterial endotoxin levels exceeding safety limits, but the actual risk depends on proper testing and use.
Contact Tornier directly for specific guidance on your implant and next steps.
Check for the lot number 3268BA and reference code DWM003A on your implant label.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-3155-2024 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-3155-2024 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.
