Biomet, Inc.: Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

Is my product affected?

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

• UPC 00880304554412
• UPC 00880304506084

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

What happened

Biomet, Inc. is recalling 15 units of Regenerex Series-A Patella 3 Peg knee prostheses (31 MM and 37 MM models) distributed worldwide, including across the United States and multiple international locations. The recall was issued because these knee implants may contain elevated endotoxin levels that exceed the product's specification limits.

The affected products are identified by two specific lot numbers: UDI Number 561760 (01)00880304554412(17)211229(10)561760 and UDI Number 091090 (01)00880304506084(17)211214(10)091090. The source does not specify what remedy or action affected consumers should take.

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: 15 units Lot/code info: Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090

Source

Official record: FDA (Device enforcement) ↗

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

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