ConforMIS, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0148-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)

Product Classification:

Class II

Date Initiated: August 31, 2015
Date Posted: October 28, 2015
Recall Number: Z-0148-2016
Event ID: 72108
Reason for Recall:

May contain small amounts of ethylene glycol residue

Status: Terminated
Product Quantity: 1 unit
Code Information:

Serial Number: OUS 0354195

Distribution Pattern:

Distributed Nationwide and in Germany, Switzerland, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated