ConforMIS, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0144-2016)

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 iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111

Product Classification:

Class II

Date Initiated: August 31, 2015

Date Posted: October 28, 2015

Recall Number: Z-0144-2016

Event ID: 72108

Reason for Recall:

May contain small amounts of ethylene glycol residue

Status: Terminated

Product Quantity: 3 units

Code Information:

Serial Numbers (US): 0354697, 0353789, 0354533

Distribution Pattern:

Distributed Nationwide and in Germany, Switzerland, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated