180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
Check against the official notice below — it lists the full affected range.
Stryker Instruments Division of Stryker Corporation is recalling 708 units of its 180-Gram Cement Cartridge with Breakaway Femoral Nozzle (Product Number 0206-530-000) due to lack of sterility assurance. Testing found that bioburden levels in affected units exceeded the company's internal acceptable rates. The affected product was distributed across all 50 U.S. states and the District of Columbia, as well as internationally in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom.
The recall affects two lot numbers: 17277012 and 17283012. The source does not specify a remedy or recommended consumer action.
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: 708 Lot/code info: Lot Numbers: 17277012, 17283012 UDI: (01)4546540857880
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.