Z-1243-2018 Class II Terminated
FDA device recall Z-1243-2018 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: 384.
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
- 384
Product Description
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 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
Lot Number: 17279012 UDI: (01)4546540039415