1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 1,244 AutoPlex System units and AutoPlex System units with VertaPlex HV due to lack of sterility assurance. The bioburden levels (the amount of microorganisms present) were found to be higher than the company's internal acceptable rates. The affected products were distributed across all 50 U.S. states and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom.
The recall involves specific lot numbers of these surgical instruments. According to the recall record provided, no remedy has been specified.
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: 1244 Lot/code info: 1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.