—#177052

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.

FDA product code: NDL — Pin, Fixation, Smooth, Metallic
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 351-90-22; UDI Number: 10885862567529; Expiration Date: 08/28/2028; Serial Numbers (6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, 6189273); Packaging Lots Numbers (49079322, 49079321); Manufacturing Lot Number:19030412

Why it was recalled

Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.

Root cause (FDA determination)

Error in labeling

Action the firm took

Exactech notified customers on about 10/02/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that the 2.4mm x 2.5" Fluted Pin Pouch was found to contain a single pin rather than four (4) as labeled. Instructions included to immediately cease distribution or use of the affected product, provide the information to customers if further distributed, identify and quarantine any of the affected devices in inventory, and complete and return the provided Recall Acknowledgement Form and Recall Inventory Response Form to Exactech via email to recalls@exac.com.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: US Nationwide distribution in the states of GA, NY, OH, VA.

Timeline

Recall initiated: 2019-10-02
Terminated: 2023-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.