DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injec...
FDA Device Recall #Z-1436-2021 — Class II — April 1, 2021
Recall Summary
| Recall Number | Z-1436-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 1, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Leibinger GmbH & Co. KG |
| Location | Freiburg Im Breisgau, N/A |
| Product Type | Devices |
| Quantity | 321 units |
Product Description
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.
Reason for Recall
Inability for the user to inject the paste from the syringe into the target location.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
Lot / Code Information
Lot: DI20311,DI20307 Product Code (UDI): 07613327123265
Other Recalls from Stryker Leibinger GmbH & Co. KG
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1885-2024 | Class II | 8000-021-002, Scopis¿ ENT Software with TGS¿ wi... | Apr 4, 2024 |
| Z-1785-2024 | Class II | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Inte... | Mar 29, 2024 |
| Z-1234-2023 | Class II | Patient-Fitted Temporomandibular (TMJ) Reconstr... | Dec 6, 2022 |
| Z-0715-2022 | Class II | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog... | Dec 29, 2021 |
| Z-2902-2018 | Class II | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE ... | Jun 22, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.