Tibial Total Ankle Prosthesis Tray recall: Labeling Error
Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
Why was Tibial Total Ankle Prosthesis Tray recalled?
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
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?
180894 181152
- Product
- Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 2029
- Distribution
- Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.
- Recall date
- April 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)