1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 504 units of two iVAS System Kit products (11g/10mm model number 0705-310-000 and 11g/15mm model number 0705-315-000) due to lack of sterility assurance. The manufacturer found that bioburden levels—the amount of microorganisms present on the products—exceeded internal acceptable rates. The affected products were distributed across all 50 U.S. states, Washington D.C., and multiple countries including Canada, Australia, Japan, the United Kingdom, France, Spain, Italy, Netherlands, Argentina, Chile, and Korea.
The recall involves specific lot numbers: lot 17277012 (12-month shelf life) and lots 17283012 and 17299012 (36-month shelf life). The source document does not specify what action affected consumers 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: 504 Lot/code info: 1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012 UDI: (01)7613252505983; (01)7613252505969
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.