Events

Recall of Device Recall Tibial baseplate

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

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
    64588
  • Event Risk Class
    Class 2
  • Event Number
    Z-1379-2013
  • Event Initiated Date
    2013-02-20
  • Event Date Posted
    2013-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118171
  • 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
    The recall of the loaner bin and sterilization trays for implants and instruments was initiated by orthopedic alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Action
    A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Device

Device Recall Tibial baseplate
  • Model / Serial
    Catalog No. 2203-3010 2203-3020 2203-3030 2203-3040 2203-3050 2203-3060 2303-1211 2303-1212 2303-1213 2303-1214 2303-1215 2303-1221 2303-1222 2303-1223 2303-1224 2303-1225 2303-1231 2303-1232 2303-1233 2303-1234 2303-1235 2303-1241 2303-1242 2303-1243 2303-1244 2303-1245 2303-1251 2303-1252 2303-1253 2303-1254 2303-1255 2303-1261 2303-1262 2303-1263 2303-1264 2303-1265 2303-3011 2303-3012 2303-3013 2303-3014 2303-3015 2303-3021 2303-3022 2303-3023 2303-3024 2303-3025 2303-3031 2303-3032 2303-3033 2303-3034 2303-3035 2303-3041 2303-3042 2303-3043 2303-3044 2303-3045 2303-3051 2303-3052 2303-3053 2303-3054 2303-3055 2303-3061 2303-3062 2303-3063 2303-3064 2303-3065
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
  • Product Description
    Tibial baseplate,cemented,#1 2203-3010 || Tibial baseplate,cemented,#2 2203-3020 || Tibial baseplate,cemented,#3 2203-3030 || Tibial baseplate,cemented,#4 2203-3040 || Tibial baseplate, cemented, #5 2203-3050 || Tibial baseplate, cemented, #6 2203-3060 || Tibial insert,CR,plained,#1,9mm 2303-1211 || Tibial insert,CR,plained,#1,11mm 2303-1212 || Tibial insert,CR,plained,#1,13mm 2303-1213 || Tibial insert,CR,plained,#1,15mm 2303-1214 || Tibial insert,CR,plained,#1,18mm 2303-1215 || Tibial insert,CR,plained,#2,9mm 2303-1221 || Tibial insert,CR,plained,#2,11mm 2303-1222 || Tibial insert,CR,plained,#2,13mm 2303-1223 || Tibial insert,CR,plained,#2,15mm 2303-1224 || Tibial insert,CR,plained,#2,18mm 2303-1225 || Tibial insert,CR,plained,#3,9mm 2303-1231 || Tibial insert,CR,plained,#3,11mm 2303-1232 || Tibial insert,CR,plained,#3,13mm 2303-1233 || Tibial insert,CR,plained,#3,15mm 2303-1234 || Tibial insert,CR,plained,#3,18mm 2303-1235 || Tibial insert,CR,plained,#4,9mm 2303-1241 || Tibial insert,CR,plained,#4,11mm 2303-1242 || Tibial insert,CR,plained,#4,13mm 2303-1243 || Tibial insert,CR,plained,#4,15mm 2303-1244 || Tibial insert,CR,plained,#4,18mm 2303-1245 || Tibial insert,CR,plained,#5,9mm 2303-1251 || Tibial insert,CR,plained,#5,11mm 2303-1252 || Tibial insert,CR,plained,#5,13mm 2303-1253 || Tibial insert,CR,plained,#5,15mm 2303-1254 || Tibial insert,CR,plained,#5,18mm 2303-1255 || Tibial insert,CR,plained,#6,9mm 2303-1261 || Tibial insert,CR,plained,#6,11mm 2303-1262 || Tibial insert,CR,plained,#6,13mm 2303-1263 || Tibial insert,CR,plained,#6,15mm 2303-1264 || Tibial insert,CR,plained,#6,18mm 2303-1265 || Tibial insert, PS , #1, 9mm 2303-3011 || Tibial insert, PS , #1, 11mm 2303-3012 || Tibial insert, PS , #1, 13mm 2303-3013 || Tibial insert, PS , #1, 15mm 2303-3014 || Tibial insert, PS , #1, 18mm 2303-3015 || Tibial insert, PS , #2, 9mm 2303-3021 || Tibial insert, PS , #2, 11mm 2303-3022 || Tibial insert, PS , #2, 13mm 2303-3023 || Tibial insert, PS , #2, 15mm 2303-3024 || Tibial insert, PS , #2, 18mm 2303-3025 || Tibial insert, PS , #3, 9mm 2303-3031 || Tibial insert, PS , #3, 11mm 2303-3032 || Tibial insert, PS , #3, 13mm 2303-3033 || Tibial insert, PS , #3, 15mm 2303-3034 || Tibial insert, PS , #3, 18mm 2303-3035 || Tibial insert, PS , #4, 9mm 2303-3041 || Tibial insert, PS , #4, 11mm 2303-3042 || Tibial insert, PS , #4, 13mm 2303-3043 || Tibial insert, PS , #4, 15mm 2303-3044 || Tibial insert, PS , #4, 18mm 2303-3045 || Tibial insert, PS , #5, 9mm 2303-3051 || Tibial insert, PS , #5, 11mm 2303-3052 || Tibial insert, PS , #5, 13mm 2303-3053 || Tibial insert, PS , #5, 15mm 2303-3054 || Tibial insert, PS , #5, 18mm 2303-3055 || Tibial insert, PS , #6, 9mm 2303-3061 || Tibial insert, PS , #6, 11mm 2303-3062 || Tibial insert, PS , #6, 13mm 2303-3063 || Tibial insert, PS , #6, 15mm 2303-3064 || Tibial insert, PS , #6, 18mm 2303-3065 || Variety of hip and knee implants and instruments, multiple uses.
  • Manufacturer
    Orthopedic Alliance LLC

Manufacturer

Orthopedic Alliance LLC
  • Manufacturer Address
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA