Stryker Howmedica Osteonics Corp. recalls LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed…
- Recall date
- August 29, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0378-2017
- FDA classification
- Class II
- Brand / firm
- Stryker Howmedica Osteonics Corp.
- Sold / distributed
- US Nationwide and Internationally
Why it was recalled
Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
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