Z-0201-2016Class II

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant...

Name: Z-0201-2016 Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant...
Creator: Exactech, Inc.
Published: 2015-09-23
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2015-09-23 / Terminated

FDA source

Exactech, Inc. began a recall of Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation on 2015-09-23. FDA classified it as Class II and gives the reason as "Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0201-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-23
Posted: 2015-11-02
Terminated: 2017-03-01
Recalling firm: Exactech, Inc.
Product: Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
FDA root cause: Under Investigation by firm
Action: The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email [email protected]. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative. Any questions contact your Exactech inventory representative at [email protected] or 1-800-392-2832.
Quantity in commerce: 8
Distribution: US Distribution to states of: AZ, CO, FL, and MD.
Product codes and lots: Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0201-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0201-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-02

Product code MEH

K080980Class IIExactech Novation Element Press-Fit Femoral StemsExactech, Inc. / cleared 2008-05-06

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)