The Recall Desk
ModerateFDA (Devices)·Z-0445-2014·Announced 2013-12-11

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

Smith & Nephew is recalling 45 units of 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: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries. The hazard is a potential loss of sterility due to a seal defect, which fits the criteria for a moderate risk where the hazard is theoretical or precautionary without reported harm.

Plain-English summary

Smith & Nephew Inc. is recalling 45 units of the GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM (REF 71420820). 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 (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 12GT20824.

This is an FDA Class II recall. The source text does not report any illnesses or injuries associated with this defect. Healthcare providers and patients should check their inventory for this specific reference number and batch number. If the product is found, it should be removed from use and returned to Smith & Nephew Inc. according to their instructions.

The recalled product

Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Manufacturer
Smith & Nephew Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
45

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. 12GT20824

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 →

Related recalls

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Same hazard · sterility compromise

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