Exactech Recalls Truliant Splined Stem Extensions Due to Labeling Error
Exactech is recalling four Truliant Splined Stem Extensions because the labels incorrectly identify the implant size as 17mm x 80mm instead of 18mm x 120mm.
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: The recall is classified as FDA Class II and involves a minor labeling error regarding product dimensions, which fits the criteria for a moderate severity recall.
Plain-English summary
Exactech, Inc. is recalling four units of the Truliant Splined Stem Extension, 18mm x 120mm. These devices are used in a cemented total knee prosthesis system for primary and revision total knee arthroplasty.
The recall was initiated due to a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm, whereas the actual implant size is 18mm x 120mm.
The affected units were distributed nationwide in the states of Arizona, Colorado, and Florida. The specific units involved have catalog number 02-012-64-1812 and serial numbers 6366405, 6367075, and 6367076. Healthcare providers should verify the size of the implants in their inventory against the correct specifications.
The recalled product
- Product
- Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 4
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 (3)
- Catalog no: 02-012-64-1812 Serial number: 6366405
- 6367075
- 6367076
Distribution
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