Events

Recall of Beuchal Pappas Mobile Bearing Knee System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endotec, 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
    60138
  • Event Risk Class
    Class 2
  • Event Number
    Z-0431-2012
  • Event Initiated Date
    2011-09-21
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104501
  • 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
    Prothesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
  • Reason
    On 09/21/2011 endotec, orlando, fl initiated a recall for the beuchel-pappas mobile bearing knee system (bp knee). the bp mobile bearing knee system consists of unapproved mobile (rotating) bearing tibial and patellar components.
  • Action
    Endotec sent an "URGENT: MEDICAL DEVICE RECALL" letter dated September 21, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to examine and quarantine product subject to the recall. Additionally, a Response Form was included with the letter for customers to complete and return to the firm. Call 862-703-6730 for questions regarding this recall.

Device

Beuchal Pappas Mobile Bearing Knee System
  • Model / Serial
    04330001Z001NN435 04330001Z005NN436 K04330002A1NN459 K04330002A2NN712 04330003ONN700 04330004NNN462 K04330004B1NN702 04330005Z001NN435 04330005NNN459 K04330005AANN733 04330005AANN736 04330005ABNN751 04330006Z001NN437 04330006H1NN749
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide) including the states of AZ, CA, CT, FL, NE, NJ, OH, and OK.
  • Product Description
    "***BUECHEL-PAPPAS Conforming Bearing***UHMWPE***SIZE***CAT**STERILE***ENDOTEC***Endotec, Inc. 300 Sunport Lane, Suite 500 Orlando, FL 32809 USA***" || SIZE 1 x 0mm CAT 04-33-0001; || SIZE 2 x 0mm CAT 04-33-0002; || SIZE 3 x 0mm CAT 04-33-0003; || SIZE 4 x 0mm CAT 04-33-0004; || SIZE 5 x 0mm CAT 04-33-0005; || SIZE 6 x 0mm CAT 04-33-0006. || Tricompartmental Knee Replacement
  • Manufacturer
    Endotec, Inc.

Manufacturer

Endotec, Inc.
  • Manufacturer Address
    Endotec, Inc., 300 Sunport Ln Ste 500, Orlando FL 32809-8123
  • Manufacturer Parent Company (2017)
    Cellumed Co., Ltd.
  • Source
    USFDA