Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0446-2014·Announced 2013-12-11

Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

Smith & Nephew is recalling 80 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

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, which typically corresponds to a moderate severity where the hazard is unlikely to cause serious injury but may cause temporary or reversible harm. The specific defect is a packaging seal issue, which is a lower-risk contamination or sterility concern compared to active pathogen exposure.

Plain-English summary

Smith & Nephew Inc. is recalling 80 units of the GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM (REF 71421508). 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 (specifically mentioning Nevada) and international markets including 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 12GT20822.

Consumers and healthcare providers should stop using these devices and contact Smith & Nephew for instructions on return or replacement. 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, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Manufacturer: Smith & Nephew Inc
Category: Medical Device — Orthopedic Implant
Hazard: sterility-compromise
packaging-defect
Affected units: 80

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. 12GT20822

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.

See all 6 products in this recall →

Same manufacturer · Smith & Nephew Inc

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