RecallRadar

FDA Device recall Z-0148-2016

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

On 2015-10-28 the FDA classified a Class II recall of ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS) by Conformis, citing may contain small amounts of ethylene glycol residue.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0148-2016
ClassificationClass II
Statusterminated
Initiated2015-08-31
Published2015-10-28
Last updated2026-09-13 11:53 UTC
CompanyConformis
DistributionUS

Product

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

Reason

May contain small amounts of ethylene glycol residue

Identifiers

code_infoSerial Number: OUS 0354195

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0148-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.