Recall Register

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Stryker GmbH

FDA recalling firm · 21 enforcement events · 75 product records · 2018–2026 · N/A

Stryker GmbH has 21 FDA enforcement events on this register (75 product records) between 2018 and 2026: 21 device; the busiest year was 2018 with 6.

0% of its events are Class I; the most common class is Class II (21). 9 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
1 Jul 2026Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.DeviceClass II7Ongoing
28 May 2025Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.DeviceClass II1Ongoing
22 May 2025Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.DeviceClass II2Ongoing
28 Mar 2025Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;DeviceClass II2Ongoing
9 May 2024Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.DeviceClass II1Ongoing
7 Feb 2023stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achievedDeviceClass II1Ongoing
28 Mar 2022Smart Toe II Intramedullary Arthrodesis ImplantDeviceClass II1Ongoing
27 May 2021Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407SDeviceClass II2Ongoing
25 Sep 2020Osteosynthesis Compression Staple EasyClipDeviceClass II1Ongoing
7 May 2020Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.DeviceClass II15Terminated
5 Dec 2019Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050DeviceClass II1Terminated
21 Nov 2019Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity…DeviceClass II1Terminated
25 Jul 2019Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.DeviceClass II13Terminated
30 Apr 2019Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1DeviceClass II2Terminated
21 Jan 2019Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee ArthroplastyDeviceClass II1Terminated
28 Aug 2018Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and…DeviceClass II4Terminated
26 Jul 2018Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002DeviceClass II1Terminated
27 Jun 2018Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115SDeviceClass II1Terminated
4 May 2018Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463DeviceClass II1Terminated
27 Apr 2018Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231SDeviceClass II16Terminated
12 Mar 2018Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.DeviceClass II1Terminated

By type and class

Device21
Class II21

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

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for Stryker GmbH by year initiated.

Questions and answers

How many FDA recalls has Stryker GmbH had?

21 enforcement events (75 product records) on this register, 2018–2026: 21 device.

Are any Stryker GmbH recalls ongoing?

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

What class are Stryker GmbH recalls?

21 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.