DePuy Mitek VAPR Hook Electrode Recalled for Incorrect Labeling
DePuy Mitek is recalling 376 VAPR Hook Electrodes because the packaging may display the wrong product identification label.
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 the hazard is a minor labeling error regarding product identification without reported injuries or illnesses.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 376 units of the VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece (Catalog Number: 227305). The recall is due to a labeling error where the large product identification label on the box may incorrectly indicate a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode.
The affected product is intended for use with the VAPR Radiofrequency System for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist. The specific lot number is M1108086.
The product was distributed nationwide in the United States, including the states of AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, NJ, NY, OH, OR, TN, TX, UT, VA, and WA. Healthcare providers and facilities should verify their inventory against the lot number and contact DePuy Mitek for further instructions.
The recalled product
- Product
- DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation…
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 376
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 (1)
- Lot Number: M1108086
Distribution
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