Tornier, Inc recalls stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the…
- Recall date
- August 29, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3155-2024
- FDA classification
- Class II
- Brand / firm
- Tornier, Inc
- Sold / distributed
- US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Why it was recalled
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
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