Exactech, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2966-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 13, 2018

Date Posted: September 12, 2018

Recall Number: Z-2966-2018

Event ID: 80667

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.

Status: Terminated

Product Quantity: 7 units

Code Information:

GTIN10885862525629, Lot Number 098299003

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated