Enforcement Report - Week of September 12, 2012
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Product Detail
| Product Description | OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. |
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| Recall Number | Z-2310-2012 |
| Classification | Class II |
| Code Info | Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots. |
| Product Distributed Qty | 193 |
| Reason For Recall | Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification. |
Event Detail
| Event Id | 61984 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Exactech, Inc. |
| City | Gainesville |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-08-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL. |
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