Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.

Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Code information: Lot Numbers: 17282012, 17283012, 17297012, 17298012 UDI: (01)4546540055415

Distribution pattern: Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.