Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 46 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.
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: This is an FDA Class II recall involving a potential sterility breach (packaging defect) with no reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smith & Nephew Inc. is recalling 46 units of the GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM (REF 71421516). The recall is due to a defect where the Tyvek(TM) 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) sterilized orthopedic devices. The distribution pattern includes the United States (including Nevada) and international markets in the United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany, and the United Kingdom. The specific batch number is 12GT20775.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The FDA has not reported any illnesses or injuries associated with this specific recall in the provided text.
The recalled product
- Product
- GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 46
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. 12GT20775
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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