Conformis, Inc. recalls iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
- Recall date
- August 22, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0063-2020
- FDA classification
- Class II
- Brand / firm
- Conformis, Inc.
- Sold / distributed
- Distributed to consignees in MD and NV.
Why it was recalled
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
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