The Recall Desk

FDA (Devices) recall action 85108

Conformis, Inc. recalled 2 products on 2020-04-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-04-08
Critical
0
Units
6

Why these products were recalled

A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2020-04-08

    Conformis Recalls iTotal CR Knee Replacement System Due to Labeling Error

    Conformis, Inc. is recalling four iTotal CR Knee Replacement System kits because they were labeled with incorrect serial numbers and delivered to the wrong customers.

    Product
    iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2020-04-08

    Conformis Recalls iTotal PS Knee Replacement System Due to Labeling Error

    Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.

    Product
    iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be…
    Category
    Distribution
    3 states