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
Check against the official notice below — it lists the full affected range.
Exactech, Inc. recalled 9 units of its 2.4mm x 2.5 Fluted Pin Pouch (Catalog Number 351-90-22), an orthopedic surgical instrument used during implantation of the Vantage Total Ankle System. The recall was issued because pouches had the potential to contain only a single pin instead of the intended four pins. The affected units were distributed nationwide in Georgia, New York, Ohio, and Virginia.
The recalled pouches have UDI Number 10885862567529 and an expiration date of 08/28/2028, with the following serial numbers: 6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, and 6189273 (packaging lot numbers 49079322 and 49079321; manufacturing lot number 19030412). The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Reason for recall: Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended. Distribution: US Nationwide distribution in the states of GA, NY, OH, VA. Quantity: 9 units 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.