Conformis, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0475-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.

Product Classification:

Class II

Date Initiated: September 21, 2020

Date Posted: December 2, 2020

Recall Number: Z-0475-2021

Event ID: 86615

Reason for Recall:

Incorrect hip components were provided in kits.

Status: Terminated

Product Quantity: 2

Code Information:

Serial numbers 0469255, 0469255

Distribution Pattern:

US Distribution in CA.

Voluntary or Mandated:

Voluntary: Firm initiated