Exactech Equinoxe Reverse Drill Bit Kit Recalled for Incorrect Components
Exactech is recalling Equinoxe Reverse Drill Bit Kits because they may contain two 2mm drill bits instead of the intended 2mm and 3.2mm combination.
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, which typically corresponds to a moderate severity score when no specific hospitalization or serious injury reports are present in the source text.
Plain-English summary
Exactech, Inc. is recalling two units of the Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00. The product is used for shoulder surgery. The recall was initiated because the kits may contain two 2mm diameter drill bits instead of the intended one 2mm diameter drill bit and one 3.2mm diameter drill bit.
The affected units have serial numbers 5214432 and 5214445. These products were distributed in Australia and France. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
Healthcare providers and patients should stop using the affected drill bit kits and contact Exactech, Inc. for further instructions or a replacement.
The recalled product
- Product
- Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 2
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 (2)
- Serial Numbers: 5214432
- 5214445
Distribution
Distributed in 1 state:
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