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Recall Observatory FDA recall evidence

Device 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

Z-2177-2018

May 18, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80185
Status
Terminated
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-2177-2018

Official wording

Reason: 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.

Code information: Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340

Distribution pattern: US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.