OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use wi...
FDA Device Recall #Z-2310-2012 — Class II — August 19, 2011
Recall Summary
| Recall Number | Z-2310-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 19, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Exactech, Inc. |
| Location | Gainesville, FL |
| Product Type | Devices |
| Quantity | 193 |
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.
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.
Distribution Pattern
USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
Lot / Code Information
Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
Other Recalls from Exactech, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1509-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo M... | Feb 3, 2026 |
| Z-1510-2026 | Class II | Brand Name: Equinoxe Product Name: Equinoxe C... | Feb 3, 2026 |
| Z-0536-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjust... | Sep 5, 2025 |
| Z-0537-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Ergo A... | Sep 5, 2025 |
| Z-0535-2026 | Class II | Brand Name: Equinoxe Ergo Product Name: Adjust... | Sep 5, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.