Z-2966-2018Class II

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

Name: Z-2966-2018 Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements
Creator: Exactech, Inc.
Published: 2018-07-13
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2018-07-13 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements on 2018-07-13. FDA classified it as Class II and gives the reason as "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". 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-2966-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-13
Posted: 2018-10-11
Terminated: 2021-04-22
Recalling firm: Exactech, Inc.
Product: Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm notified their direct consignees by email on 07/13/2018 and requested the return of the product.
Quantity in commerce: 7 units
Distribution: CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
Product codes and lots: GTIN10885862525629, Lot Number 098299003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2966-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2966-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-08-31

Product code LXH

K152217Class IIExactech Vantage Total Ankle SystemExactech, Inc. / cleared 2016-03-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)