Z-2148-2020 Class II Terminated
FDA device recall Z-2148-2020 was initiated by Biomet, Inc. on April 17, 2020 and is designated Class II. Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit The recall status is terminated (terminated June 25, 2021). Affected quantity: 76 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 17, 2020
- Termination Date
- June 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 units
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
Reason for Recall
Potential presence of elevated endotoxin levels that exceed the specification limit
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.
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