Biomet Vanguard M Unicondylar Tibial Trial Recalled for Incorrect Etching
Biomet, Inc. is recalling 27 Vanguard M Unicondylar Tibial Trials because the left and right orientation markings are incorrectly etched on the handle.
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, which typically corresponds to a moderate severity score. The hazard is a labeling error that could cause confusion but does not involve a high-risk pathogen or structural defect leading to immediate severe injury.
Plain-English summary
Biomet, Inc. is recalling 27 units of the Vanguard M Unicondylar Tibial Trial, a medical device used during knee joint replacement surgery. The recall is due to a manufacturing error where the left and right orientation markings on the handle are incorrectly etched.
The defect causes the handle to display 'R' on the same side as the keel marked 'LM' and 'L' on the same side as the keel marked 'RM' when the instrument is rotated 180 degrees. This incorrect labeling could lead to confusion regarding the orientation of the trial during use. The affected units were distributed worldwide, including in the United States (specifically Illinois and New Jersey), Canada, the Netherlands, and Chile.
Healthcare providers and facilities that have received these specific part numbers and lot numbers should stop using the affected instruments and contact Biomet, Inc. for instructions on return or replacement. The specific affected lots include Part 32-423101 (Lots 414930, 785170), Part 32-423102 (Lots 116490, 785180), Part 32-423106 (Lot 785220), Part 32-423107 (Lot 873780), Part 32-423108 (Lots 070420, 785250), Part 32-423109 (Lots 670630, 785260), Part 32-423115 (Lot 672920), Part 32-423119 (Lot 785290), Part 32-423116 (Lot 073640), Part 32-423124 (Lot 024760), and Part 32-423110 (Lot 785270).
The recalled product
- Product
- Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 27
Distribution
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