Total Knee Pack - Surgical Kit recall: Sterility Concern
Total Knee Pack - Surgical Kit
Why was Total Knee Pack - Surgical Kit recalled?
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
- Product
- Total Knee Pack - Surgical Kit
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Quantity
- 76 units
- Distribution
- US Nationwide distribution in the states of IN, TX, and PA.
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)