Smith & Nephew Dyonics Electroblade Resector Recalled for Labeling Error
Smith & Nephew is recalling Dyonics Electroblade Resectors labeled with an incorrect 48-month expiry date instead of 36 months.
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 regarding expiry dates where reliability for the extra period is unvalidated, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Smith & Nephew, Inc. Endoscopy Division is recalling 340 units of the Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER (Part Number 72202213). The recall affects specific lot numbers: 950135R, 950136R, 950137R, and 950138R. The devices were distributed worldwide, including the United States, Australia, Canada, Korea, Turkey, UAE, and Japan.
The recall was initiated because the devices were labeled with an expiry period of 48 months instead of the correct 36 months. The additional 12 months of shelf life have not been validated for product and package reliability. The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures for soft and osseous tissue resection and hemostasis.
Healthcare providers and facilities should stop using the affected devices and contact Smith & Nephew for instructions on return or disposal. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade…
- Manufacturer
- Smith & Nephew, Inc. Endoscopy Division
- Hazard
- Affected units
- 340
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 (4)
- Lot Numbers: 950135R
- 950136R
- 950137R
- 950138R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew, Inc. Endoscopy Division 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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