1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 5,988 InterPulse Handpiece instruments used in medical procedures because bioburden levels—the amount of microorganisms present—were found to be higher than the company's internal acceptable rates, creating a lack of sterility assurance. The affected handpieces were 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 involves multiple lot numbers across different handpiece models. Consumers can identify affected products by checking their lot numbers and UDI codes against those listed in the recall notice. The source document does not specify a remedy or instructions for what consumers should do regarding the recalled products.
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: 5988 Lot/code info: 1. Lot Numbers: 17283012, 17284012, 17286012; 2. Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. Lot Number: 17279012; 4. Lot Number: 17284012 UDI: (01)4546540861641; (01)4546540861764; (01)4546540861818; (01)4546540144300
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.