Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor recalled over sterility concerns
- Recall date
- August 18, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Stryker Howmedica Osteonics Corp. recalls Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp…
- Recall number
- Z-0060-2017
- FDA classification
- Class II
- Brand / firm
- Stryker Howmedica Osteonics Corp.
- Sold / distributed
- US and Internationally
Why it was recalled
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
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 Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
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