• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Echo BiMetric PressFit Stems/Echo BiMetric 11mm x 135mm Collarless Porous Stem

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Echo BiMetric PressFit Stems/Echo BiMetric 11mm x 135mm Collarless Porous Stem
see related information
Date Posted November 27, 2012
Recall Status1 Terminated on August 28, 2013
Recall Number Z-0442-2013
Recall Event ID 63711
Premarket Notification
510(K) Number
K070274 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
Product Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
Code Information Catalog Number: 192411 and Lot Number Identification: 244800
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Manufacturer Reason
for Recall
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions: ® Immediately locate and remove the identified device(s) listed below from circulation. ® Carefully follow the instructions on the enclosed FAX Back Response Form. ® Fax a copy of the Response Form to 574-372-1683 prior to return of product. ® Use priority carrier for your shipment. Questions related to notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 4
Distribution Nationwide distribution: USA including states of: AZ, MD, and KS.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = BIOMET MANUFACTURING CORP.
-
-