Biomet, Inc.: 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, Lef

Is my product affected?

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

• UPC 00880304180703
• UPC 00880304180833
• UPC 00880304180864
• UPC 00880304180666
• UPC 00880304180680
• UPC 00880304180741
• UPC 00880304180802
• UPC 00880304180819
• UPC 00880304180826
• UPC 00880304180840
• UPC 00880304180888
• UPC 00880304180925
• UPC 00880304180963
• UPC 00880304181069
• UPC 00880304181076
• UPC 00880304180727
• UPC 00880304180956
• UPC 00880304180918

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling 105 units of Vanguard M Partial Knee System MonoBlock Tibial Tray knee implants due to the potential presence of elevated endotoxin levels that exceed specification limits. The recalled products were distributed worldwide, including throughout the United States and to Canada, India, Japan, Mexico, Singapore, Thailand, and numerous other countries. The affected devices are identified by specific lot numbers and UDI numbers listed in the recall notice, with expiration dates ranging from December 2021 to early 2022.

The recall notice does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential presence of elevated endotoxin levels that exceed the specification limit

Details from the source

Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit Distribution: 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. Quantity: 105 units Lot/code info: 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(

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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