FDA-Device2019-11-20Class II
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
Exactech, Inc.
Hazard
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Sold states
US Nationwide distribution in the states of GA, NY, OH, VA.
Affected count
9 units
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional technique for total ankle replacement. These instruments are single-use, provided sterile, and intended for transient use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0361-2020Don't want to check this manually?
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