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Conformis, Inc. recalls Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Recalled June 19, 2019 · FDA recall Z-1776-2019 · Conformis
Hazard
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants. · FDA Class II
Units
183
Sold at
Nationwide
Description
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Product
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Manufacturer(s)
Conformis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →