ConforMIS, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0143-2016)

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 Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)

Product Classification:

Class II

Date Initiated: August 31, 2015

Date Posted: October 28, 2015

Recall Number: Z-0143-2016

Event ID: 72108

Reason for Recall:

May contain small amounts of ethylene glycol residue

Status: Terminated

Product Quantity: 12 units

Code Information:

Serial Numbers (US): 0354902, 0353696 Serial Numbers (OUS): 0349179 0352344 0352431 0352626 0353845 0353883 0353884 0354625 0355002 0355181

Distribution Pattern:

Distributed Nationwide and in Germany, Switzerland, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated