Medical Device Recall: 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
Biomet, Inc. · March 13, 2024
Reason for Recall
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Product Description
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.
Distribution
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
States Affected
NATIONWIDE
Quantity Affected
19 units (1 US, 18 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1607-2024
Status: ongoing
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