Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure
Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.
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 an FDA Class II recall for a medical device (knee replacement prosthesis) where a real functional defect—loss of vacuum integrity in a component—has been documented in three complaints affecting four devices. This qualifies as a risk-of-harm scenario for a medical device product, warranting a High severity rating per the rubric criterion.
Plain-English summary
The Exactech Optetrak Logic Knee System is an orthopedic knee replacement prosthesis. The recalled devices are identified by specific catalog numbers (02-012-47-3011, 02-012-47-5009, 02-012-47-5011, and 02-012-65-3013) and serial numbers (A676497, A641353, A641341, and A655561). These devices were distributed to medical facilities across multiple U.S. states and in several countries worldwide.
The recall concerns loss of vacuum in the inner-most vacuum bag, which is a component of the device system. Loss of vacuum can potentially compromise device integrity and performance. Exactech has identified three complaints related to this issue involving four devices.
This is a Class II recall issued by the FDA. Additional information regarding the recall, including specific details about which units are affected, is available from the FDA and the manufacturer Exactech, Inc.
The recalled product
- Product
- Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
- Manufacturer
- Exactech, Inc.
- Hazard
- vacuum-loss
- device-integrity
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 (12)
- a) 02-012-47-3011
- GTIN 10885862174352
- Serial Numbers: A676497
- b) 02-012-47-5009
- GTIN 10885862174543
- Serial Numbers: A641353
- c) 02-012-47-5011
- GTIN 10885862174550
- Serial Numbers: A641341
- d) 02-012-65-3013
- GTIN 10885862613400
- Serial Numbers: A655561
Distribution
Distributed in 16 states:
- AR
- FL
- GA
- IL
- IN
- KY
- MD
- ME
- MN
- NH
- NV
- NY
- SC
- TN
- TX
- VA
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