ConforMIS, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0140-2016)

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 iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)

Product Classification:

Class II

Date Initiated: August 31, 2015

Date Posted: October 28, 2015

Recall Number: Z-0140-2016

Event ID: 72108

Reason for Recall:

May contain small amounts of ethylene glycol residue

Status: Terminated

Product Quantity: 6 units

Code Information:

Serial Numbers (US): 0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233

Distribution Pattern:

Distributed Nationwide and in Germany, Switzerland, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated