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Recall Observatory FDA recall evidence

Device product

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

Z-2966-2018

July 13, 2018

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 80667
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-2966-2018

Official wording

Reason: 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.

Code information: GTIN10885862525629, Lot Number 098299003

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.