Smith & Nephew Knee Prosthesis Component Recalled for Incorrect Labeling
Smith & Nephew recalled a knee prosthesis component after a complaint indicated the package contained the wrong size and type of implant instead of what was labeled. This product substitution could result in incorrect implant during surgery.
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: FDA Class II recall involving a surgical implant product substitution where the wrong prosthesis component was shipped instead of the labeled component. No reported illnesses or injuries are documented in the source text, placing this in the risk-of-harm category per the severity rubric.
Plain-English summary
Smith & Nephew Inc. issued a recall of LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW (reference number 71421275) following a complaint that indicated incorrect product packaging. A package was found to contain a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of the GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT that was labeled on the packaging.
This product substitution represents a risk because the wrong prosthesis component could be inadvertently implanted during surgery, resulting in surgical complications.
Eight units of the affected product were distributed in the United States to Mississippi, Tennessee, North Carolina, California, Georgia, Delaware, and Alabama, and also distributed to Canada. The recall involves batch number 23LM02905 (UDI/DI 00885556234204).
Customers who may have received this product should contact Smith & Nephew Inc. to verify they have the correct component and to determine the appropriate next steps.
The recalled product
- Product
- smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
- Manufacturer
- Smith & Nephew Inc
- Hazard
- product-mislabeling
- wrong-implant
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 00885556234204
- Batch number 23LM02905
Distribution
Distributed in 7 states:
- AL
- CA
- DE
- GA
- MS
- NC
- TN
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