Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 1,542 Advanced Cement Mixing (ACM) Kits with Femoral Breakaway Nozzles and Proximal Medial Pressure devices (Product Number 0306-573-000) used in orthopedic procedures. The recall affects kits from Lot Numbers 17282012, 17283012, 17297012, and 17298012 that were distributed across all 50 U.S. states, Washington D.C., and 11 other countries including Canada, Japan, the United Kingdom, Australia, and several European nations. The kits are being recalled because bioburden levels—the amount of microorganisms present—were found to exceed the manufacturer's internal acceptable rates, creating a lack of sterility assurance.
The recall was initiated due to concerns that the affected kits may not meet required sterility standards for use in surgical procedures. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Reason for recall: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. Distribution: 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. Quantity: 1542 Lot/code info: Lot Numbers: 17282012, 17283012, 17297012, 17298012 UDI: (01)4546540055415
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.