Tornier recalls specific shoulder implant components (Aequalis Pyrocarbon Humeral Heads) due to potential graphite exposure. Affected models include catalog numbers DWH039 to DWH154 with varying diameters and heights. Consumers should check their implant details and contact Tornier for guidance.
Potential patient exposure to the graphite substrate.
Tornier is recalling specific shoulder implant components (Aequalis Pyrocarbon Humeral Heads) that may expose patients to graphite. This recall affects implants with catalog numbers from DWH039 to DWH154, which vary in size and height. If you have one of these implants, contact Tornier directly for instructions.
The implants contain a graphite substrate that could potentially expose patients to graphite during use. This risk is related to the material composition of the implant and may cause health issues if the graphite is released into the body.
Patients who received a shoulder implant from Tornier with catalog numbers DWH039 to DWH154 are affected. Those with the highest risk are individuals who have undergone surgery using these specific implant components.
Check your implant's catalog number, which ranges from DWH039 to DWH154. The implants have specific diameters (39mm to 54mm) and heights (14mm to 23mm). They were sold only outside the U.S. and Canada.
Identify your implant's catalog number, diameter, and height to confirm if it is in the recall list (DWH039 to DWH154).
Reach out to Tornier directly for further instructions on how to address the recall.
The recall indicates a potential risk of graphite exposure, but the implants are not inherently unsafe. Patients should check their specific model and contact Tornier for guidance.
Check your implant's catalog number, which ranges from DWH039 to DWH154. The implants have specific diameters (39mm to 54mm) and heights (14mm to 23mm).
Contact Tornier directly for instructions on how to address the recall. They will provide specific guidance based on your implant details.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-2291-2021 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-2291-2021 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.