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Exactech, Inc. recalls 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the
Recalled November 20, 2019 · FDA recall Z-0361-2020 · Exactech
Hazard
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended. · FDA Class II
Units
9 units
Sold at
US Nationwide distribution in the states of GA, NY, OH, VA.
Description
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Product
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.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →