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Terminated

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

FDA Recall Z-2966-2018 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2018-07-13
Date Terminated2021-04-22
Product Quantity7 units

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.

Firm Action

The firm notified their direct consignees by email on 07/13/2018 and requested the return of the product.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152217Exactech Vantage Total Ankle SystemExactech, Inc. · 2016-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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