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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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)…
- Manufacturer
- Exactech, Inc.
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
Part of a larger recall action
This product is one of 12 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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