Z-1250-2018 Class II Terminated
FDA device recall Z-1250-2018 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: 1244.
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
- 1244
Product description
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
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 Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1250-2018
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026