FDA Device recall Z-2310-2012
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***R…
- FDA Device
- Class II
- terminated
- Published 2012-09-12
On 2012-09-12 the FDA classified a Class II recall of OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***R… by Exactech, citing 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 specificati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2310-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-08-19 |
| Published | 2012-09-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Exactech |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2310-2012%22
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