ReUnion TSA Shoulder System recalled over sterility concerns
- Recall date
- May 12, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Stryker Howmedica Osteonics Corp. recalls ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgi…
- Recall number
- Z-2363-2015
- FDA classification
- Class II
- Brand / firm
- Stryker Howmedica Osteonics Corp.
- Sold / distributed
- US Nationwide
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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