Z-1030-2017 Class II Terminated
FDA device recall Z-1030-2017 was initiated by Exactech, Inc. on Nov 7, 2016 and is designated Class II. Reason for recall: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. The recall status is terminated (terminated Aug 5, 2019). Affected quantity: 79 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2017
- Initiation Date
- Nov 7, 2016
- Termination Date
- Aug 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 79 units
Product Description
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Reason for Recall
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Distribution Pattern
AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1030-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026