Z-3209-2018Class II

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use...

Name: Z-3209-2018 Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use...
Creator: Exactech, Inc.
Published: 2018-05-08
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2018-05-08 / Open, Classified

FDA source

Exactech, Inc. began a recall of Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary... on 2018-05-08. FDA classified it as Class II and gives the reason as "Potentially have non-conforming internal threads". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3209-2018
Classification: Class II
Status: Open, Classified
Initiated: 2018-05-08
Posted: 2018-09-20
Recalling firm: Exactech, Inc.
Product: Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Potentially have non-conforming internal threads.
FDA root cause: Under Investigation by firm
Action: The firm, Exactech, contacted the consignee on May 3, 2018 by telephone to notify the consignee to quarantine the device pending recall notice distribution. Exactech distributed an "URGENT MEDICAL DEVICE RECALL" notice dated May 7, 2018 to the consignee in possession of affected inventory by electronic mail on May 7, 2018. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech at [email protected]. On May 15, 2018, the recalled device was returned to Exactech and quarantined. If you have any questions, contact Sr. Manager, Regulator Affairs at 352-327-4613.
Quantity in commerce: 1
Distribution: US Distribution to Ohio only.
Product codes and lots: Catalog #: 02-012-60-2216 Serial Number: 5370045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3209-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3209-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-09-26	2018-09-20

Product code JWH

K150890Class IIExactech Optetrak Logic CCExactech, Inc. / cleared 2015-05-29

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)