Exactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility
Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.
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 involves a medical device with a functional defect (dimensional incompatibility) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Exactech, Inc. of Gainesville, FL is recalling 70 units of the Optetrak Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm. The recall was initiated after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
The affected products are sterile and are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement or revision of failed previous reconstructions. The specific catalog number for the recalled items is 02-012-42-2508.
The products were distributed nationwide in the United States, including the states of AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA. Healthcare providers and patients should stop using these specific spacers and contact Exactech, Inc. for further instructions.
The recalled product
- Product
- OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals underg
- Manufacturer
- Exactech, Inc.
- Affected units
- 70
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 (1)
- Catalog Number: 02-012-42-2508.
Distribution
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