Events

Recall of Device Recall ConFormis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConforMIS, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72108
  • Event Risk Class
    Class 2
  • Event Number
    Z-0147-2016
  • Event Initiated Date
    2015-08-31
  • Event Date Posted
    2015-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140006
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    May contain small amounts of ethylene glycol residue.
  • Action
    ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.

Device

Device Recall ConFormis
  • Model / Serial
    Serial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269  Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247  Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed Nationwide and in Germany, Switzerland, and UK.
  • Product Description
    ConFormis iTotal Posterior Stabilized Knee Replacement System- || ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and || ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT || Catalog Number:TPS1111111
  • Manufacturer
    ConforMIS, Inc.

Manufacturer

ConforMIS, Inc.
  • Manufacturer Address
    ConforMIS, Inc., 28 Crosby Dr, Bedford MA 01730-1402
  • Manufacturer Parent Company (2017)
    Conformis Inc
  • Source
    USFDA