Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2150-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

Product Classification:

Class II

Date Initiated: April 17, 2020

Date Posted: June 3, 2020

Recall Number: Z-2150-2020

Event ID: 85524

Reason for Recall:

Potential presence of elevated endotoxin levels that exceed the specification limit

Status: Terminated

Product Quantity: 46 units

Code Information:

Lot Numbers: UDI Number 443160 Knees Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM (01)00880304271869(17)211230(10)443160 458440 Knees Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM (01)00880304271852(17)220105(10)458440 376090 Knees Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM (01)00880304436947(17)220113(10)376090 678080 Knees Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM (01)00880304436954(17)220119(10)678080

Distribution Pattern:

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

Voluntary or Mandated:

Voluntary: Firm initiated