Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 8 units of Genesis II mobile bearing articular inserts because the Tyvek lid may not be adequately sealed.
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. The hazard involves a potential packaging seal defect which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria for minor defects or precautionary recalls.
Plain-English summary
Smith & Nephew Inc is recalling 8 units of the Genesis II Mobile Bearing Articular Insert, Right, Size 5, 9 mm (Reference 71621509). The recall is due to a defect where the Tyvek lid on one or both of the two trays forming the double barrier around the insert may not have been adequately sealed.
The affected units are sterile ethylene oxide (EO) products from Batch No. 12GT20940. These devices were distributed worldwide, including in the United States (specifically Nevada) and internationally to the United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany, and the United Kingdom.
Healthcare providers and facilities should stop using the affected inserts and contact Smith & Nephew for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 8
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)
- Batch No. 12GT20940
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 6 recalled by Smith & Nephew Inc 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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