Reported Apr 28, 2021 · Terminated
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the…
Stryker Leibinger GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Leibinger GmbH & Co. KG · Botzinger Str. 41 · Freiburg Im Breisgau, N/A · N/A
Is this the product you have?
- DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
- Lot codes and dates
- LotDI20311
- DI20307 Product Code (UDI)07613327123265
- Amount recalled
- 321 units
Where it was sold
- Nationwide
Why it was recalled
Inability for the user to inject the paste from the syringe into the target location.
This product could cause temporary or reversible health problems — stop using it.
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