Z-1248-2018 Class II Terminated
FDA device recall Z-1248-2018 was initiated by Stryker Instruments Div. Of Stryker Corporation on Nov 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 Apr 16, 2019). Affected quantity: 1542.
Recall details
- Product Type
- Devices
- Report Date
- Apr 4, 2018
- Initiation Date
- Nov 9, 2017
- Termination Date
- Apr 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1542
Product description
Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 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 Numbers: 17282012, 17283012, 17297012, 17298012 UDI: (01)4546540055415
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1248-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026