Z-0906-2015Class II

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog...

Name: Z-0906-2015 Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog...
Creator: Exactech, Inc.
Published: 2014-10-09
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2014-10-09 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants on 2014-10-09. FDA classified it as Class II and gives the reason as "Mislabeled". 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-0906-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Posted: 2015-01-05
Terminated: 2016-06-08
Recalling firm: Exactech, Inc.
Product: Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Mislabeled
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking. If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.
Quantity in commerce: 96
Distribution: International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Product codes and lots: Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0906-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0906-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05

Product code JWH

K033883Class IIOptetrak Total Knee System, Hi-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, Hi-Flex Posterior-StabiExactech, Inc. / cleared 2004-02-13

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)