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
Product summary
- 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
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.