ConforMIS, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0139-2016)

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 Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

Product Classification:

Class II

Date Initiated: August 31, 2015

Date Posted: October 28, 2015

Recall Number: Z-0139-2016

Event ID: 72108

Reason for Recall:

May contain small amounts of ethylene glycol residue

Status: Terminated

Product Quantity: 71 units

Code Information:

Serial Numbers (US): 0353901 0354506 0354220 0355550 0355016 0350789 0354111 0354321 0352939 0353154 0353812 0354828 0354576 0354180 0355588 0355064 0353912 0351237 0351983 0354434 0353374 0351642 0352751 0355557 0353757 0353944 0354218 0353846 0353688 0355110 0352483 0345608 0353771 0353306 3054517 Serial Numbers (OUS): 0348705 0349592 0351522 0351616 0352700 0352750 0352827 0352840 0352999 0353210 0353225 0353263 0353420 0353514 0353515 0353577 0353714 0353791 0353822 0353918 0353921 0354163 0354208 0354284 0354292 0354439 0354507 0354509 0354605 0354771 0354773 0354792 0355178 0355188 0355202 0355227

Distribution Pattern:

Distributed Nationwide and in Germany, Switzerland, and UK.

Voluntary or Mandated:

Voluntary: Firm initiated