Zimmer Biomet, Inc.: Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total

Is my product affected?

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

• UPC 00880304005310

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

What happened

Zimmer Biomet is recalling one lot of 75mm Biomet Modular Primary Tibial Tray implants (Lot 385340) because the components are potentially etched and labeled as 79mm tibial trays instead of their actual size. This labeling error could result in surgeons implanting an incorrectly sized tibial component, which may cause delays in surgery or require immediate revision surgery to remove and replace the cemented component. A total of 16 units were distributed across Florida, Georgia, Indiana, Massachusetts, New Mexico, Utah, and Wisconsin in the United States, as well as to Canada and Mexico.

The recall notice does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

Details from the source

Reason for recall: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented. Distribution: US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico Quantity: 16 Lot/code info: Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340

Source

Official record: FDA (Device enforcement) ↗

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

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