DirectInject consists of a sterile dual paste system recall
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a…
Why was DirectInject consists of a sterile dual paste system recalled?
Inability for the user to inject the paste from the syringe into the target location.
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?
Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
- Product
- DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a…
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 321 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)