Food, drugs, devices › Stryker Leibinger GmbH & Co. KG
Device recall: QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Ac
FDA enforcement event 76146 is a device recall by Stryker Leibinger GmbH & Co. KG of Freiburg, N/A, initiated 3 Jan 2017 and classified Class II, with 2 product records.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 27 Jul 2017. 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, N/A, Germany.
Reason for recall
"An incorrect sterility status on the label, non-sterile products labeled as sterile"
Distribution
"Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1149-2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System | 619 | Class II | Terminated | 15 Feb 2017 |
| Z-1150-2017 | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants | 619 | Class II | Terminated | 15 Feb 2017 |
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 |
| 1 Apr 2021 | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer- | 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 |
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: "An incorrect sterility status on the label, non-sterile products labeled as sterile"
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 - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Jul 2017. "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.