Z-2086-2014Class II

NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended...

Name: Z-2086-2014 NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended...
Creator: Exactech, Inc.
Published: 2014-03-07
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2014-03-07 / Terminated / root cause: design

FDA source

Exactech, Inc. began a recall of NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our... on 2014-03-07. FDA classified it as Class II and gives the reason as "The femoral stem is lacking specified plasma coating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2086-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-07
Posted: 2014-07-21
Terminated: 2014-08-04
Recalling firm: Exactech, Inc.
Product: NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: The femoral stem is lacking specified plasma coating.
Root cause tag: design
FDA root cause: Component design/selection
Action: Exactech sent an Important Product Recall Notice dated March 10, 2014, to all affected customers. The notice identified the product the problem and the action to be taken by the customer. Description of Issue: The femoral stem is lacking specified plasma spray coating. Clinical Impact: Without plasma spray coating, the stem may not remain stable and will not have the possibility for biological fixation. In order to comply with applicable regulations and Exactech policies customers were instructed to : " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Determine if they have any of the affected devices " Fax back the attached form. Complete the attached fax back form and return it to Exactech. Customers were instructed to contact their Exactech inventory representative within 5 business days to confirm quantities at their location. For any inventory restocking questions related to this issue, please call 1-800-392-2832. For questions regarding this recall call 800-392-2832.
Quantity in commerce: 10
Distribution: Worldwide Distribution including Spain, Greece and Japan
Product codes and lots: Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2086-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2086-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-21

Product code LZO

K042843Class IIAmbu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc. / cleared 2004-11-12

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)