Exactech, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1030-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.
Product Description:

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

Product Classification:

Class II

Date Initiated: November 7, 2016
Date Posted: January 25, 2017
Recall Number: Z-1030-2017
Event ID: 75989
Reason for Recall:

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

Status: Terminated
Product Quantity: 79 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated