Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2153-2020)

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: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

Product Classification:

Class II

Date Initiated: April 17, 2020

Date Posted: June 3, 2020

Recall Number: Z-2153-2020

Event ID: 85524

Reason for Recall:

Potential presence of elevated endotoxin levels that exceed the specification limit

Status: Terminated

Product Quantity: 93 units

Code Information:

Lot Numbers: UDI Number 294130 Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130 509970 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970 509990 Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990 175980 Knees Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM (01)00880304438354(17)220114(10)175980 294130R Knees Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM (01)00880304438262(17)211219(10)294130R 509970R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)211230(10)509970R 509990R Knees Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM (01)00880304476714(17)220103(10)509990R

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