Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

Recall date
October 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0514-2020
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK

Why it was recalled

Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

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 X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025

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