Exactech knee replacement inserts recalled for vacuum seal loss
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The issue involves loss of vacuum in storage packaging rather than an inherent device defect, with only 3 complaints involving 4 devices received, qualifying this as a precautionary quality-control recall.
Plain-English summary
Exactech is recalling certain Truliant and Activit-E Knee Insert models due to loss of vacuum in the innermost vacuum bag. The affected devices are identified by specific catalog numbers and serial numbers included in this recall notice.
The company has received 3 complaints involving 4 devices where vacuum loss in the storage packaging was reported. No illnesses or injuries have been reported in connection with this issue.
The recalled devices were distributed to medical facilities in multiple U.S. 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 to facilities in Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, South Korea, Slovenia, Spain, and the United Kingdom.
The recalled product
- Product
- Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k) 02-02
- 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) 02-023-02-0029
- GTIN 10885862596376
- Serial Numbers: A704613
- A704614
- A704618
- A704633
- A704634
- A704649
- A704651
- A704632
- b) 02-023-02-0032
- GTIN 10885862596383
- Serial Numbers: A703837
- A703844
- A703847
- A703863
- A704084
- A704089
- A704100
- A704102
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