Smith & Nephew Recalls Genesis Knee Implants Due to Design Defect
Smith & Nephew is recalling 47 Genesis knee implants because the anterior locking detail does not meet design specifications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical implant, which meets the criteria for a Severe rating.
Plain-English summary
Smith & Nephew, Inc. is recalling 47 units of the Genesis (GII) knee implant system. The recall is due to a defect where the anterior locking detail does not meet its design specifications.
The affected devices are Model 71420966, Lot 18JY09702. These implants are designed for use in primary and revision surgery for patients where the posterior cruciate ligament and one or both collateral ligaments are absent or incompetent.
The devices were distributed worldwide, including in the United States and several international countries. Patients who have received these implants should contact their healthcare provider for further instructions.
The recalled product
- Product
- Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 47
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 (2)
- Model: 71420966
- Lot: 18JY09702
Distribution
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