2.4mm x 2.5 Fluted Pin Pouch recall
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…
Why was 2.4mm x 2.5 Fluted Pin Pouch recalled?
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Exactech, Inc.
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of GA, NY, OH, VA.
- Recall date
- November 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)