Exactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement
Exactech is recalling 18 Truliant Tibial Fit Trays because they were mismarked as size 3. The devices were distributed to facilities in 10 US states.
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: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (mismarking) without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Exactech, Inc. is recalling 18 units of the Truliant Tibial Fit Tray Cemented SZ 3F / 3T (Catalog Number 02-022-45-3030). The recall is being conducted because the devices were mismarked as size 3. These components are part of the OPTETRAK Comprehensive Knee Systems, which are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement.
The affected units were distributed nationwide to facilities in Arkansas, California, Ohio, Oklahoma, Indiana, Minnesota, New Jersey, Tennessee, South Carolina, and Florida. The specific serial numbers for the recalled units are 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, and 5774543.
Healthcare providers should check their inventory for these specific serial numbers and stop using the affected trays. Patients who have had these specific components implanted should contact their healthcare provider for further instructions.
The recalled product
- Product
- Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 18
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 (17)
- Serial Numbers: 5774515
- 5774517
- 5774518
- 5774519
- 5774520
- 5774521
- 5774525
- 5774526
- 5774527
- 5774529
- 5774531
- 5774532
- 5774533
- 5774534
- 5774535
- 5774541
- 5774543
Distribution
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