Smith & Nephew Recalls Tibial Knee Prosthesis Due to Material Defects
Smith & Nephew is recalling 1,845 tibial knee prostheses because raw material inconsistencies may cause internal non-homogenous material defects.
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 is classified as FDA Class II and involves a structural defect in a medical device (internal non-homogenous material defects) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smith & Nephew, Inc. is recalling 1,845 units of tibial knee prostheses. The recall is due to an inconsistency in the raw material process, which may result in specific lots containing units with internal non-homogenous material defects.
The affected products include models 71420164, 71420166, and 71420184. The recall covers a wide range of lot numbers, including those beginning with 19MT, 20AT, 20BT, H20, and G19. The FDA has classified this recall as Class II.
The affected units were distributed domestically to numerous U.S. states, including Alabama, Louisiana, Minnesota, Kentucky, Arkansas, Georgia, Texas, Wisconsin, New Jersey, North Carolina, Connecticut, New York, Ohio, Iowa, Indiana, Massachusetts, South Carolina, Nevada, West Virginia, Michigan, Tennessee, Florida, Arizona, Pennsylvania, and Missouri. International distribution included countries such as Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Czech Republic, Denmark, Spain, France, Great Britain, Greece, Hungary, India, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Russia, Sweden, Slovenia, Turkey, and Ukraine.
Consumers and healthcare providers should check their inventory for the specific model and lot numbers listed in the recall notice. If a unit matches the recalled description, it should be removed from use and returned to Smith & Nephew or the distributor according to the firm's instructions.
The recalled product
- Product
- Tibial knee prosthesis
- Manufacturer
- Smith & Nephew, Inc.
- Hazard
- Affected units
- 1,845
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 (20)
- Model: 71420164
- 71420166 and 71420184 Lot Numbers: 19MT31457
- 19MT31458
- 19MT31459
- 20AT32611
- 20AT32612
- 20AT32613
- 20AT33540
- 20AT33541
- 20AT33542
- 20AT33543
- 20AT33544
- 20AT33545
- 20AT33546
- 20AT33547
- 20AT33548
- 20AT33569
- 20AT33570
- 20AT33571
- 20BT33856
Distribution
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