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

• Date Initiated by Firm: November 06, 2012
• Date Posted: November 27, 2012
• Recall Status: Terminated on August 28, 2013
• Recall Number: Z-0442-2013
• Recall Event ID: 63711
• 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 IN 46582-6989
• For Additional Information Contact: 574-267-6639 Ext. 1676
• 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: 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWA