Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
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 medical device recall with loss of vacuum in sterile packaging that could compromise device integrity. Although no illnesses or injuries have been reported, the defect represents a potential risk of harm in an orthopedic implant used in surgical procedures.
Plain-English summary
Exactech, Inc. is recalling specific units of the Truliant Knee System, an orthopedic implant device used in knee replacement surgery. These units were distributed to healthcare facilities in 16 U.S. states and to multiple international countries including Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, and the United Kingdom.
The recall is due to loss of vacuum in the inner-most vacuum bag. Exactech has received three complaints related to this defect affecting four devices in total. No illnesses or injuries have been reported.
Healthcare providers and facilities who have received these products should review their inventory to identify any units with the affected catalog numbers and serial numbers. For specific information about the defect and recommended actions, healthcare providers should consult Exactech or the FDA recall notice.
The recalled product
- Product
- Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
- Manufacturer
- Exactech, Inc.
- Hazard
- vacuum-loss
- sterility-risk
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) 02-012-35-3509
- GTIN 10885862304346
- Serial Numbers: A730624
- A730626
- A730628
- A730630
- A730631
- A730632
- A730633
- b) 02-022-35-1509
- GTIN 10885862303974
- Serial Numbers: A641578
- A683756
- A683757
- A683758
- A683759
- c) 02-022-35-1513
- GTIN 10885862304018
- Serial Numbers: A662293
- d) 02-022-35-3010
Distribution
Distributed in 16 states:
- AR
- FL
- GA
- IL
- IN
- KY
- MD
- ME
- MN
- NH
- NV
- NY
- SC
- TN
- TX
- VA
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03