Biomet, Inc.: Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis

Is my product affected?

Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis

• UPC 00880304006492

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

What happened

Biomet, Inc. is recalling 12 units of its Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard knee prosthesis due to the potential presence of elevated endotoxin levels that exceed the product's specification limit. The affected devices were distributed worldwide, including throughout the United States and in Canada, India, Japan, Thailand, Singapore, Taiwan, the Netherlands, Mexico, Chile, Costa Rica, and several other countries. The recall involves devices with Lot Number/UDI Number 292720 (01)00880304006492(17)211222(10)292720.

The source document does not specify a remedy or recommended action for consumers who may have received this product.

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: 12 units Lot/code info: Lot Numbers: UDI Number 292720 (01)00880304006492(17)211222(10)292720

Source

Official record: FDA (Device enforcement) ↗

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

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