The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0131-2014·Announced 2013-11-13

Smith & Nephew Recalls Swapped Genesis II Tibial Base Implants

Smith & Nephew is recalling four units of Genesis II tibial base implants due to packaging errors where size 5 left and size 6 right components were swapped.

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 involves a temporary or medically reversible adverse health consequence. The hazard is a packaging error (swapped sizes) rather than a material defect or contamination, and no injuries or illnesses are reported in the source text.

Plain-English summary

Smith & Nephew Inc is recalling four units of the Genesis II Non-Porous Tibial Base, Size 6, Right (Ref 71420188). The recall is due to a packaging error where a non-porous tibial base size 5 left was mis-packaged as size 6 right, and vice versa.

The affected units are identified by Batch No. 13GM09505. The products were distributed nationwide in the United States to the states of Arizona, North Carolina, Iowa, Pennsylvania, Ohio, Maryland, and Tennessee.

Healthcare providers and patients should check their inventory and records for this specific reference number and batch. If the product has been implanted, patients should contact their orthopaedic surgeon to discuss the potential implications of the size mismatch.

The recalled product

Product
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Manufacturer
Smith & Nephew Inc
Category
Medical Device — Orthopaedic Implants
Hazard
Affected units
4

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. 13GM09505

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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