Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2148-2020)

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: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 154361 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, C4 154366 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, D4 154370 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154377 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 159575 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM Product Usage: Knee prosthesis

Product Classification:

Class II

Date Initiated: April 17, 2020

Date Posted: June 3, 2020

Recall Number: Z-2148-2020

Event ID: 85524

Reason for Recall:

Potential presence of elevated endotoxin levels that exceed the specification limit

Status: Terminated

Product Quantity: 76 units

Code Information:

Lot Numbers: Product UDI Number 666130 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 (01)05019279515226(17)211226(10)666130 570480 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 (01)05019279515240(17)211223(10)570480 589030 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 (01)05019279515301(17)211226(10)589030 602820 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 (01)05019279515493(17)211226(10)602820 328350 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 (01)05019279515646(17)211223(10)328350 560530 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 (01)05019279999453(17)211226(10)560530 827910 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 (01)05019279999453(17)211224(10)827910 786780 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 (01)05019279999460(17)211226(10)786780 602860 Knees Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 (01)05019279999477(17)211223(10)602860 374340 Knees Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM (01)05019279786213(17)211228(10)374340 374340 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM (01)05019279786213(17)211228(10)374340

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