OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier
Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.
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: This is a Class II FDA recall involving a risk-of-harm medical device (orthopedic implant) where the packaging defect could compromise sterility. Although no illnesses or injuries have been reported, the potential for serious patient harm from non-sterile implants justifies a High severity rating.
Plain-English summary
Exactech, Inc. recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts, which are used in knee replacement procedures. The recall encompasses seven product line variants (PS, PSC, CR, CR Slope+, CR Slope++, CRC, and CC) and affects devices distributed worldwide, including throughout the United States and to over 40 additional countries.
The inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. This packaging deficiency creates a risk that the devices' sterility or integrity could be compromised during storage and transportation before use.
The FDA classified this as a Class II recall. Affected devices are identified by product line numbers (02-012-35-XXXX, 02-012-44-XXXX, 02-012-47-XXXX and others) and specific serial numbers. The recall was initiated in February 2022.
The recalled product
- Product
- OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXX
- Manufacturer
- Exactech, Inc.
- Hazard
- packaging-defect
- sterility-compromise
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 (20)
- a. Item Number (Device Identifier
- Serial number(s)): 02-012-35-0009 (10885862001641
- 1678465
- 1678471
- 1678474
- 1678481
- 1957753
- 2006036
- 2006037
- 2013812
- 2043308
- 2092688
- 2554898
- 2573058
- 4705904)
- 02-012-35-0011 (10885862001658
- 1678302
- 1678309
- 1678312
- 1963089
Distribution
Distributed nationwide across the United States.
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