Z-2704-2017Class II

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

Name: Z-2704-2017 Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Creator: Exactech, Inc.
Published: 2017-04-07
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-04-07 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Exactech Optetrak Logic CC 15mm Tibial Augment Screws on 2017-04-07. FDA classified it as Class II and gives the reason as "Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2704-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-07
Posted: 2017-06-19
Terminated: 2020-08-04
Recalling firm: Exactech, Inc.
Product: Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at [email protected] or 800-392-2832.
Quantity in commerce: 9 devices
Distribution: CA and NY.
Product codes and lots: Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2704-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2704-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-08

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)