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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