Z-1246-2018 Class II Terminated
FDA device recall Z-1246-2018 was initiated by Stryker Instruments Div. of Stryker Corporation on November 9, 2017 and is designated Class II. Reason for recall: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. The recall status is terminated (terminated April 16, 2019). Affected quantity: 5988.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- November 9, 2017
- Termination Date
- April 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5988
Product Description
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: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.
Reason for Recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Distribution Pattern
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.
Code Information
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