FDA-Device2024-09-25Class II
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Tornier, Inc
Hazard
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Sold states
US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Affected count
5 units
Manufactured in
10801 Nesbitt Ave S, Bloomington, MN, United States
Products
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3155-2024Don't want to check this manually?
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