Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure
Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.
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 FDA Class II medical device recall with no reported illnesses or injuries. While loss of vacuum in a surgical implant represents a potential device integrity issue that could affect patient safety, the hazard remains theoretical. The limited number of complaints relative to distribution scope supports a High severity rating per rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
Exactech, Inc. is recalling specific catalog numbers of the Optetrak Knee System, a surgical implant used in knee replacement procedures. The affected devices include 14 catalog numbers with specific serial numbers ranging from model 200-02-26 through 208-24-13.
The recall is due to loss of vacuum in the inner-most vacuum bag. Exactech has received 3 complaints regarding 4 affected devices related to this issue. The vacuum bag functions as a protective barrier for the implant.
The affected devices have been distributed in multiple US states including New York, Texas, Indiana, Illinois, Minnesota, Kentucky, Virginia, Maryland, Tennessee, Georgia, New Hampshire, Maine, South Carolina, Nevada, Florida, and Arkansas, as well as internationally in Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom.
At this time, no illnesses or injuries have been reported. Patients who have received one of the affected devices should consult with their healthcare provider about their specific device and any concerns.
The recalled product
- Product
- Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
- Manufacturer
- Exactech, Inc.
- Hazard
- vacuum-seal-failure
- 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 (20)
- a) 200-02-26
- GTIN 10885862039576
- Serial Numbers: A736412
- b) 200-02-29
- GTIN 10885862039583
- Serial Numbers: A689481
- A689501
- A689515
- A708024
- A708032
- A708035
- A708038
- A708050
- A708077
- A708082
- A708092
- A708100
- A708111
- c) 200-02-32
- GTIN 10885862039590
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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