Device product
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Z-1030-2017
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 75989
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79 units
- Official record key
device-enforcement:Z-1030-2017
Official wording
Reason: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Code information: Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086
Distribution pattern: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Derived failure modes
-
Unknown
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.