Food, drugs, devices › Stryker Leibinger GmbH & Co. KG
Device recall: DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-
Stryker Leibinger GmbH & Co. KG (Freiburg Im Breisgau, N/A) initiated this device recall on 1 Apr 2021; FDA lists 1 product record under event 87684, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 19 Dec 2022. Initiation: voluntary: firm initiated. Stryker Leibinger GmbH & Co. KG has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, N/A, Germany.
Reason for recall
"Inability for the user to inject the paste from the syringe into the target location."
Distribution
"Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1436-2021 | 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. | 321 units | Class II | Terminated | 28 Apr 2021 |
Context
Other enforcement events for Stryker Leibinger GmbH & Co. KG
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Apr 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution | Device | Class II | 1 |
| 29 Mar 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony | Device | Class II | 1 |
| 6 Dec 2022 | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | Device | Class II | 1 |
| 29 Dec 2021 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Device | Class II | 1 |
| 22 Jun 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Ster | Device | Class II | 18 |
| 3 Jan 2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Ac | Device | Class II | 2 |
All 7 events for Stryker Leibinger GmbH & Co. KG
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Inability for the user to inject the paste from the syringe into the target location."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Dec 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.