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U.S. Department of Health and Human Services

Enforcement Report - Week of December 5, 2012

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Event Detail

Event ID 63711
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-06
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide distribution: USA including states of: AZ, MD, and KS.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog Number: 192411 and Lot Number Identification: 244800 Class II It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. 4 Z-0442-2013
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