Genesis II Tibial Baseplate Devices Recalled for Packaging Error
Smith & Nephew recalled 31 Genesis II Tibial Baseplate devices that were mispackaged with contents not matching the outer box label. This could result in implanting the wrong-sized component during knee surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of surgical implant components due to packaging and labeling errors. While no illnesses or injuries have been reported, the mispackaging creates a risk that surgeons could inadvertently implant the wrong-sized component during surgery, qualifying it as a risk-of-harm product with a severity score of 3 per the rubric.
Plain-English summary
Smith & Nephew, Inc. is recalling 31 Genesis II Non-Porous Tibial Baseplate components used in knee replacement surgery. The recalled devices consist of two specific products: Genesis II Non-Porous Tibial Baseplate Size 5 Right (Product #71420186, Lot #21DM14954S) and Genesis II Non-Porous Tibial Baseplate Size 4 Left (Product #71420166, Lot #21FM13870A), both expiring in October 2030.
The devices were mispackaged, with the components inside the inner tray not matching the label on the outer box and accompanying documentation. This mislabeling creates a risk that surgeons could inadvertently implant the wrong-sized tibial baseplate during knee replacement surgery.
The affected devices were distributed nationwide to hospitals and surgical centers in Arizona, California, Georgia, Kansas, Louisiana, Minnesota, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Oregon, South Carolina, Tennessee, Virginia, Washington, and Wisconsin. Healthcare providers should immediately quarantine any remaining units matching the recalled lot numbers and verify correct component identification before implantation. Patients who may have received these devices should contact their healthcare provider.
The recalled product
- Product
- (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 31
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 (4)
- Product #71420186 - Lot #21DM14954S
- exp. October 2030
- UDI #03596010206350. Product #71420166 - Lot #21FM13870A
- UDI #03596010206268.
Distribution
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