FDA recall Z-1775-2019

Product

Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)

Reason for recall

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-03-29

Report date

2019-06-19

Termination date

2020-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2019