Medical device recalls Moderate risk

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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