Tornier Aequalis Pyrocarbon Humeral Heads Recall: Graphite Exposure Risk
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.
Lower-risk recall
Potential patient exposure to the graphite substrate.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/62302-tornier-aequalis-pyrocarbon-humeral-heads-recall-graphite-exposure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62302-tornier-aequalis-pyrocarbon-humeral-heads-recall-graphite-exposure-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2291-2021
Cite this page
“Tornier Aequalis Pyrocarbon Humeral Heads Recall: Graphite Exposure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62302-tornier-aequalis-pyrocarbon-humeral-heads-recall-graphite-exposure-risk. Based on FDA recall #Z-2291-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2291-2021%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Tornier- Category
Medical device
What to do — step by step
Check Your Implant Details
Identify your implant's catalog number, diameter, and height to confirm if it is in the recall list (DWH039 to DWH154).
Contact Tornier
Reach out to Tornier directly for further instructions on how to address the recall.
Where it went and when
Where it was distributed
Distributed in 15 states.
FDA distribution: “CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX and WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Connecticut, Florida, Kansas, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Pennsylvania, Texas, Wisconsin.
Recall timeline
FDA published this recall 2 months 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-2291-2021 (June 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2291-2021 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.