Z-0953-2013Class II

Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm...

Name: Z-0953-2013 Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm...
Creator: Exactech, Inc.
Published: 2013-02-01
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2013-02-01 / Terminated / root cause: design

FDA source

Exactech, Inc. began a recall of Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508 on 2013-02-01. FDA classified it as Class II and gives the reason as "A dimensional mismatch was identified which can potentially allow for interference between devices". 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-0953-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Posted: 2013-03-15
Terminated: 2014-09-22
Recalling firm: Exactech, Inc.
Product: Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A dimensional mismatch was identified which can potentially allow for interference between devices.
Root cause tag: design
FDA root cause: Device Design
Action: Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Customers were instructed to immediately cease distribution or use of these products. 2. Extend this information to your accounts that may have this product in their possession. 3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots. Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter. For further questions please call (352) 377-1140.
Quantity in commerce: 123 devices
Distribution: Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
Product codes and lots: Catalog # 02-012-42-3508 All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0953-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0953-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-15

Product code JWH

K071738Class IIExactech Optetrak Proximal Tibial SpacerExactech, Inc. / cleared 2007-08-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)