medical Class II Updated 2018-06-20

Zimmer Biomet, Inc. recalls Biomet Modular Primary Tibial Tray Implants; Modular Interlo

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: FL, GA, IN, MA, NM, UT, WI
Lot/Code Info: Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340
View official government recall

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