Recall – Discrepancy in displayed software measurement and manufactured implant

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

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.