CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report

Tibial Alignment Guide recalled by Exactech

Exactech is recalling Tibial Alignment Guide, distributed in 7 states. The recall was initiated on 13 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN10885862525629, Lot Number 098299003

Quantity recalled7 units

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-2966-2018
FDA event ID: 80667
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 13 Jul 2018
FDA classified: 31 Aug 2018
Reported: 12 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

13 Jul 2018	Recall initiated by company
31 Aug 2018	Classified by FDA	+49 days
12 Sep 2018	Published in enforcement report	+12 days

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

Reason for recall

Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.

Product as listed by the FDA

Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.

Where it was distributed

CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK

California Florida New York Ohio Oklahoma South Carolina Texas

Questions about this recall

Is Tibial Alignment Guide recalled?

Yes. Exactech recalled Tibial Alignment Guide on 13 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-2966-2018.

Why was it recalled?

Which lots are affected?

GTIN10885862525629, Lot Number 098299003

Where was it sold?

CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK

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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