Smith & Nephew Knee Prosthesis Component Packaging Error: Wrong Implant Shipped
Smith & Nephew is recalling a knee prosthesis component after discovering some packages contained a different implant than labeled. No illnesses or injuries have been reported.
What this means for you
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 where the wrong implant model and side were shipped instead of the labeled component. No illnesses or injuries have been reported, but the product mismatch presents a risk of harm if the incorrect implant is used.
Plain-English summary
Smith & Nephew Inc. is recalling the GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT (Reference 71421015, Batch 23LM02331). According to a complaint received by the company, some packages in this recall batch contained a different implant—a LEGION NARROW PS OXIN SIZE 5 RIGHT—instead of the labeled GENESIS II component.
Receiving a different knee implant model than expected could affect patient outcomes if the wrong implant is used. No illnesses or injuries related to this recall have been reported at this time.
The affected implants were distributed across eight U.S. states: Mississippi, Tennessee, North Carolina, California, Georgia, Delaware, Alabama, and to Canada. Five units in total are involved in this recall.
Patients and healthcare providers are advised to verify they received the correct implant. Any unused implants should be set aside and not used. Facilities with affected product should contact Smith & Nephew for return or replacement instructions.
The recalled product
- Product
- smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
- Manufacturer
- Smith & Nephew Inc
- Category
- Medical Device — Knee Prosthesis
- Hazard
- wrong-implant
- product-mismatch
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)
- UDI/DI 03596010469212
- Batch number 23LM02331
Distribution
Distributed in 7 states:
- AL
- CA
- DE
- GA
- MS
- NC
- TN
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