Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect
Smith & Nephew is recalling 16 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) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Smith & Nephew Inc. is recalling 16 units of the GENESIS(R) II, POSTERIAL STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM (REF 71420806). 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) products. The distribution pattern includes the United States (including Nevada) and international markets such as 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 12GT20908.
Healthcare providers and consumers should stop using these specific inserts and contact Smith & Nephew for further instructions. The FDA has classified this as a Class II recall, 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, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 16
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. 12GT20908
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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