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.
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 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 arthroplasty
- 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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