Exactech Recalls Optetrak Logic Tibial Inserts Due to Dimensional Defects
Exactech is recalling 193 Optetrak Logic Posterior Stabilized Tibial Inserts because they were found to be out of dimensional specification.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (out of dimensional specification) in a medical implant, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Exactech, Inc. of Gainesville, Florida, is recalling 193 units of the Optetrak Logic Posterior Stabilized Tibial Insert, Size 6. The recall involves three product sizes: 11mm, 13mm, and 15mm. The specific catalog numbers affected are 02-012-35-6011, 02-012-35-6013, and 02-012-35-6015, and the recall covers all lots of these items.
The recall was initiated after the devices were determined to be out of dimensional specification. 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. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
The recalled devices were distributed nationwide in the United States, specifically in Washington, Ohio, Oklahoma, Texas, North Carolina, New York, Colorado, Virginia, Massachusetts, Illinois, Tennessee, Minnesota, New Jersey, and Florida. Healthcare providers and patients should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- 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 Logi
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 193
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog numbers 02-012-35-6011
- 02-012-35-6013
- 02-012-35-6015 All lots.
Distribution
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