Enforcement Report - Week of December 5, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-0442-2013 |
| Classification | Class II |
| Code Info | Catalog Number: 192411 and Lot Number Identification: 244800 |
| Product Distributed Qty | 4 |
| Reason For Recall | It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. |
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. |
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