Biomet, Inc.: Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

Is my product affected?

Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis

• UPC 00841036226534

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

What happened

Biomet, Inc. is recalling one custom-made knee prosthesis device (TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model, Lot Number 735550) due to the potential presence of elevated endotoxin levels that exceed the specification limit. The device was distributed worldwide, including in the United States and Canada, as well as in various other countries.

The recall record does not specify a remedy 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: 1 Lot/code info: Lot Number/UDI: 735550 (01)00841036226534(17)220111(10)735550

Source

Official record: FDA (Device enforcement) ↗

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

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