Z-0136-2018Class II

Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX

Name: Z-0136-2018 Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX
Creator: Exactech, Inc.
Published: 2017-09-19
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-09-19 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX on 2017-09-19. FDA classified it as Class II and gives the reason as "There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray". 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-0136-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-19
Posted: 2017-11-20
Terminated: 2021-06-21
Recalling firm: Exactech, Inc.
Product: Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The recalling firm issued a letter dated 9/19/2017 via email to their customers.
Quantity in commerce: 683 devices
Distribution: Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0136-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0126-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0127-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0128-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0129-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0130-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0131-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0132-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0133-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0134-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0135-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0136-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0137-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0138-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0139-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0140-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0141-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0142-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0143-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0144-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0145-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0146-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0147-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0148-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0149-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0150-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0151-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0152-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0153-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0154-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0155-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0156-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0157-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0158-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20
Z-0159-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-20

Product code JWH

K023186Class IIOptetrak Total Knee System Offset Tibial TrayExactech, Inc. / cleared 2002-10-17

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)