Company: Conformis, Inc.
Date of Enforcement Report: 6/19/2019
Class II
PRODUCT
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Recall Number: Z-1775-2019
Recall Number: Z-1776-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Conformis, Inc. on 6/19/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
128
DISTRIBUTION
US Nationwide