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Biomet, Inc. recalls Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi
Recalled May 1, 2024 · FDA recall Z-1607-2024 · Biomet
Hazard
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process. · FDA Class II
Units
19 units (1 US, 18 OUS)
Sold at
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Description
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Product
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →