FDA-Device2018-09-12Class II
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Exactech, Inc.
Hazard
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.
Sold states
CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK
Affected count
7 units
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2966-2018Don't want to check this manually?
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