DePuy Mitek Recalls FMS neXtra 3.5mm Cutter Shaver Blades Due to Labeling Error
DePuy Mitek is recalling FMS neXtra 3.5mm Full Radius Cutter Shaver Blades because the blade configuration does not match the label description.
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 labeling error where the product configuration does not match the label. This fits the rubric for moderate severity involving minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 50 units of FMS neXtra 3.5mm Full Radius Cutter Shaver Blades (Product Code: 283305). The recall is due to a labeling error where the blade configuration in the affected lots does not match the description on the label.
The affected product is intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. The specific lot number is M1505055. The product was distributed worldwide, including in the US states of Texas, Ohio, Michigan, and Maine, and in the countries of France, Germany, Slovakia, Italy, the Netherlands, Switzerland, and the Czech Republic.
Healthcare providers and facilities should stop using the affected product and contact DePuy Mitek for instructions on return or replacement. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 50
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: M1505055
Distribution
Part of a larger recall action
This product is one of 3 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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