Home / Recalls / Biomet, Inc. / Z-2155-2020

Z-2155-2020 Class II Terminated

Recalled by Biomet, Inc. — Warsaw, IN

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
105 units

Product Description

Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154705 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 US154707 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 US154713 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 US154719 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 US154720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 US154721 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 US154723 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154731 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 US154735 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154746 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 US154734 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 US154730 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 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: UDI Number 570440 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 (01)00880304180703(17)211219(10)570440 548700 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 (01)00880304180833(17)211219(10)548700 560400 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 (01)00880304180864(17)211221(10)560400 630710 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 (01)00880304180666(17)211223(10)630710 570430 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 (01)00880304180680(17)211226(10)570430 690010 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 (01)00880304180741(17)211220(10)690010 560370 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 (01)00880304180802(17)211226(10)560370 630720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 (01)00880304180819(17)211226(10)630720 548690 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 (01)00880304180826(17)211227(10)548690 560390 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 (01)00880304180840(17)211227(10)560390 570450 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 (01)00880304180864(17)211223(10)570450 548720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 (01)00880304180888(17)211226(10)548720 560410 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 (01)00880304180888(17)211227(10)560410 697350 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 (01)00880304180925(17)211223(10)697350 615650 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 (01)00880304180963(17)211226(10)615650 560420 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 (01)00880304181069(17)211223(10)560420 630740 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 (01)00880304181069(17)211228(10)630740 570420 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 (01)00880304181076(17)211228(10)570420 463400 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 (01)00880304180727(17)211229(10)463400 630700 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 (01)00880304180956(17)220107(10)630700 697340 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 (01)00880304180918(17)220116(10)697340 455810 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 (01)00880304180727(17)220119(10)455810

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