Z-1030-2017Class II

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

Name: Z-1030-2017 Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15
Creator: Exactech, Inc.
Published: 2016-11-07
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2016-11-07 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15 on 2016-11-07. FDA classified it as Class II and gives the reason as "Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1030-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Posted: 2017-01-17
Terminated: 2019-08-05
Recalling firm: Exactech, Inc.
Product: Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at [email protected] or 1-800-392-2832.
Quantity in commerce: 79 units
Distribution: AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1030-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1030-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17
Z-1031-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17
Z-1032-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17

Product code JDI

K083392Class IINovation 12/14 Cemented Femoral StemsExactech, Inc. / cleared 2008-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)