Biomet, Inc.: Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System

Is my product affected?

Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 1

• UPC 00880304000865
• UPC 00880304000193
• UPC 00880304246034
• UPC 00880304003781
• UPC 00880304246096
• UPC 00880304000179
• UPC 00880304246256

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

What happened

Biomet, Inc. has recalled 54 units of AGC Knee System PS Molded Tibial Components due to the potential presence of elevated endotoxin levels that exceed specification limits. The affected products were distributed worldwide, including throughout the United States and to Canada, India, Japan, Mexico, Singapore, Thailand, Taiwan, the Netherlands, and several other countries. The recalled components come in various sizes ranging from 10 MM X 65 MM to 18 MM X 85 MM, with specific lot numbers and UDI codes identified for each affected product.

The record does not specify a remedy or recommended action for consumers who may have received these products.

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: 54 units Lot/code info: Lot Numbers: UDI Number 570460 AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM (01)00880304000865(17)220111(10)570460 515880 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220106(10)515880 602810 AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM (01)00880304246034(17)220105(10)602810 494090 AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM (01)00880304003781(17)220106(10)494090 505320 AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM (01)00880304246096(17)220106(10)505320 578470 AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM (01)00880304000193(17)220114(10)578470 447820 AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM (01)00880304000179(17)220118(10)447820 494030 AGC Knee System PS Molded Tibial component, 18 MM X 85 MM (01)00880304246256(17)220118(10)494030

Source

Official record: FDA (Device enforcement) ↗

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

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All FDA (Device enforcement) recalls