Recall Register

Food, drugs, devices › Firms

Stryker Leibinger GmbH & Co. KG

FDA recalling firm · 7 enforcement events · 25 product records · 2017–2024 · N/A

Stryker Leibinger GmbH & Co. KG has 7 FDA enforcement events on this register (25 product records) between 2017 and 2024: 7 device; the busiest year was 2021 with 2.

0% of its events are Class I; the most common class is Class II (7). 3 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
4 Apr 20248000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation…DeviceClass II1Ongoing
29 Mar 2024Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614DeviceClass II1Ongoing
6 Dec 2022Patient-Fitted Temporomandibular (TMJ) Reconstruction ProsthesisDeviceClass II1Ongoing
29 Dec 2021MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032DeviceClass II1Terminated
1 Apr 2021DirectInject 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.DeviceClass II1Terminated
22 Jun 2018QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and…DeviceClass II18Terminated
3 Jan 2017QUINTUBE 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 SystemDeviceClass II2Terminated

By type and class

Device7
Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for Stryker Leibinger GmbH & Co. KG by year initiated.

Questions and answers

How many FDA recalls has Stryker Leibinger GmbH & Co. KG had?

7 enforcement events (25 product records) on this register, 2017–2024: 7 device.

Are any Stryker Leibinger GmbH & Co. KG recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Stryker Leibinger GmbH & Co. KG recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.