Medical device recalls Moderate risk

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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