Smith & Nephew Recalls Genesis II Knee Trial Inserts Due to Color Error
Smith & Nephew is recalling nine Genesis II Cruciate Retaining Articular Insert trial units because they were produced with the wrong color material.
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. The hazard involves a manufacturing color error that could lead to the use of the wrong trial insert, but no injuries or illnesses are reported in the source text.
Plain-English summary
Smith & Nephew Inc is recalling nine units of the Genesis II Cruciate Retaining Articular Insert, Trial, Size 3-4, A/P 48 MM, M/L 68 MM, Non-Sterile, Reference 71430490. The affected devices are identified by Lot Number 12LM03798.
The recall was initiated because the products were produced using the wrong color material. The devices were manufactured in red, a color designated for deep dished inserts, instead of blue, which is the standard color for cruciate retaining inserts. This color discrepancy could lead to the incorrect selection of the trial insert during orthopedic procedures.
The affected units were distributed internationally to Germany, France, the United Arab Emirates, and the United Kingdom. No specific consumer action is detailed in the source text, but the recall is managed by Smith & Nephew Inc.
The recalled product
- Product
- GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 9
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)
- Lot Number 12LM03798
Distribution
Distribution scope not specified by the agency.
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