Smith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped
Smith & Nephew is recalling a knee prosthesis implant after a complaint indicated that a Size 3 LEFT component was shipped instead of the labeled Size 4 LEFT. Size mismatch poses a risk if the implant is placed without prior verification.
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 Class II orthopedic prosthesis recall involves a wrong-size implant that poses risk of harm if not detected before surgical placement. No reported injuries or illnesses, placing it in the risk-of-harm category per the rubric.
Plain-English summary
Smith & Nephew Inc. is recalling a LEIGON OXINIUM constrained knee prosthesis implant following a complaint that a package contained a Size 3 LEFT component instead of the Size 4 LEFT component as described on the product label.
The recalled implant (Batch 23LM00479, UDI/DI 03596010543820) was distributed to Texas in the United States and to Spain, France, and the United Kingdom. Three units were affected by this packaging and labeling discrepancy.
The size discrepancy between the implant received and the implant labeled poses a risk if not detected before implantation. Healthcare providers who received this product should verify the implant size in their inventory. Affected units should be returned to Smith & Nephew Inc.
The recalled product
- Product
- smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
- Manufacturer
- Smith & Nephew Inc
- Affected units
- 3
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 03596010543820
- Batch Number 23LM00479
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Smith & Nephew Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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