iTotal® CR iPoly™ Insert Kit RCR010000B03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M572RCR010000B031), received between May 17, 2017 and May 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K140423, K142161); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2017Packaging Problem

  THE POUCH LABELED "LATERAL POLY INSERT B" AND CONTAINING THE LATERAL B POLY INSERT WAS CONTAINED IN THE BOX LABELED "8MM MEDIAL POLY INSERT KIT". THE CORRECT POLY INSERTS WERE PROVIDED FOR SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY

  Patient problems: No Patient Involvement

  MAUDE report 6572837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140423, K142161. One submission often covers many models, so check the product and lot details in each record.

• Z-1070-2016 · Jan 28, 2016 · Terminated
  Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
• Z-0146-2016 · Aug 31, 2015 · Terminated
  ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
• Z-0144-2016 · Aug 31, 2015 · Terminated
  ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
• Z-0145-2016 · Aug 31, 2015 · Terminated
  ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
• Z-0141-2016 · Aug 31, 2015 · Terminated
  ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
• Z-0147-2016 · Aug 31, 2015 · Terminated
  ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
• Z-0581-2015 · Nov 19, 2014 · Terminated
  Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.