Zimmer, Inc.: NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Hazard

The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

Details from the source

Reason for recall: The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label. Distribution: Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME, NE, NJ, OR, SD, and TX. The countries of Canada, China, India, Netherlands, Singapore. Quantity: 76 units Lot/code info: UDI-DI: 00889024666214; Lot Numbers: 66789408, 66792792

UPC codes

00889024666214

Source

Official record: FDA (Device enforcement) ↗

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