Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient. |
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| Recall Number | Z-0416-2013 |
| Classification | Class II |
| Code Info | REF 6200-056-22, lot 62010615 |
| Product Distributed Qty | 24 USA; 71 worldwide |
| Reason For Recall | Zimmer Trilogy® Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported. |
Event Detail
| Event Id | 63541 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Zimmer, Inc. |
| City | Warsaw |
| State | IN | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-20 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK |
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