Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty |
|---|---|
| Recall Number | Z-2115-2012 |
| Classification | Class II |
| Code Info | Sizes: 1.5 mm: Catalog Number 300-10-15 Serial Range 1653131-2381151 4.5 mm: Catalog Number 300-10-45 Serial Range 1622046-2381151 |
| Product Distributed Qty | 54,877 units for all products in Recall Event |
| Reason For Recall | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year shelf life. |
Event Detail
| Event Id | 62566 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Exactech, Inc. |
| City | Gainesville |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo. |
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