Smith & Nephew Recalls Genesis II Knee Bushings Due to Labeling Error
Smith & Nephew is recalling 18 units of Genesis II knee bushings because the left and right sides were incorrectly laser marked.
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 and involves a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling 18 units of the 5-degree Genesis II Valgus Bushing (Ref Catalog Number 71440014, Lot 16MM00441). The recall is due to a laser mark labeling error where the left valgus bushing was incorrectly marked as right, and the right was marked as left.
These medical device components are indicated for use in patients with rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, or degenerative arthritis, as well as for failed osteotomies or knee replacements. The specific distribution for this lot was limited to the states of North Carolina, Indiana, Colorado, Michigan, Pennsylvania, New York, Massachusetts, and California.
Consumers and healthcare providers should stop using the affected units and contact Smith & Nephew for instructions on how to return or dispose of the product.
The recalled product
- Product
- smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and…
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 18
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 16MM00441
Distribution
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