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Conformis, Inc. recalls iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Recalled January 23, 2019 · FDA recall Z-0731-2019 · Conformis
Hazard
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. · FDA Class II
Units
1
Sold at
The products were distributed to the following US states: TN.
Description
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Product
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Manufacturer(s)
Conformis, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →