FDA recall Z-2966-2018

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-07-13

Report date

2018-09-12

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2966-2018