Smith & Nephew Recalls Mislabelled 35mm Patellar Knee Implant Components
Smith & Nephew is recalling 20 units of 35mm patellar knee implants incorrectly labeled as 32mm. The size mismatch prevents proper alignment of pegs during 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: The recall involves a medical device with a labeling error that prevents proper mechanical alignment during implantation. This is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Smith & Nephew, Inc. is recalling 20 units of GENESIS(R) II/LEGION(TM) Patellar Component, Resurfacing Round, 32mm Standard, for cemented use only with Journey Peg, sterile EO, Rx only, REF Number: 71934490. The recalled items are knee implants intended for medical use.
The recall is due to a labeling error where one lot of 35 mm patella implants is labeled as 32 mm. Because these implants have pegs that are spaced proportionally, the size mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation. The specific batch number is 15GM07831.
The affected units were distributed in the United States to the states of Florida, Missouri, Indiana, and Texas. Healthcare providers and patients should contact Smith & Nephew or their medical provider for further instructions regarding the use or replacement of these specific components.
The recalled product
- Product
- Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 20
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 (1)
- Batch # 15GM07831
Distribution
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