FDA-Device2015-08-19Class II
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
Stryker Howmedica Osteonics Corp.
Hazard
A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part # 5901-E-4818 Lot MAC7C14, offset humeral head trial.
Sold states
US Nationwide
Affected count
21 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2363-2015Don't want to check this manually?
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