The Recall Desk
ModerateFDA (Devices)·Z-0447-2014·Announced 2013-12-11

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

Smith & Nephew is recalling 32 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 hazard is a potential packaging seal failure (sterility risk) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Smith & Nephew Inc. is recalling 32 units of the GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM (REF 71421515). 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 12GT20904.

Healthcare providers and patients should check their inventory and records for this specific reference number and batch. If the product is found, it should be removed from use and returned to Smith & Nephew or the distributor according to standard recall procedures. The FDA has classified this as a Class II recall.

The recalled product

Product
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Manufacturer
Smith & Nephew Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
32

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. 12GT20904

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

Same manufacturer · Smith & Nephew Inc

See all →

Same hazard · sterility compromise

See all →