Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2156-2020)

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: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

Product Classification:

Class II

Date Initiated: April 17, 2020

Date Posted: June 3, 2020

Recall Number: Z-2156-2020

Event ID: 85524

Reason for Recall:

Potential presence of elevated endotoxin levels that exceed the specification limit

Status: Terminated

Product Quantity: 1

Code Information:

Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550

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