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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

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