Conformis, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0731-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101

Product Classification:

Class II

Date Initiated: October 16, 2018

Date Posted: January 23, 2019

Recall Number: Z-0731-2019

Event ID: 81723

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1

Code Information:

Serial Number 0424647

Distribution Pattern:

The products were distributed to the following US states: TN.

Voluntary or Mandated:

Voluntary: Firm initiated