FDA recall Z-0475-2021

Product

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.

Reason for recall

Incorrect hip components were provided in kits.

Distribution

US Distribution in CA.

Key facts

Status

Terminated

Initiation date

2020-09-21

Report date

2020-12-02

Termination date

2023-06-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2021