CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report

Optetrak Constrained Condylar Offset Screw, Size KK recalled by Exactech

Exactech is recalling Optetrak Constrained Condylar Offset Screw, Size KK, distributed in 11 states. The recall was initiated on 19 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot numbers

Quantity recalled575 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0154-2018
FDA event ID: 78111
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2017
FDA classified: 20 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Sep 2017	Recall initiated by company
20 Nov 2017	Classified by FDA	+62 days
29 Nov 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.

Where it was distributed

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.

Alabama Florida Indiana Maine Minnesota New Jersey New York Ohio Oklahoma Puerto Rico Virginia

Questions about this recall

Is Optetrak Constrained Condylar Offset Screw, Size KK recalled?

Yes. Exactech recalled Optetrak Constrained Condylar Offset Screw, Size KK on 19 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0154-2018.

Why was it recalled?

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.

Which lots are affected?

All lot numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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