Device recall: Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are…

Class II FDA enforcement event 85681. Recall start date: 7 May 2020. Status in the FDA record: Terminated. Termination date: 21 Sep 2023.

Reason for recall, in the words of FDA

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Class II, in the words of FDA

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

Stryker GmbH started this device recall on 7 May 2020. The firm address in the FDA record is in Selzach. FDA put the recall in Class II. FDA event 85681 has 15 product records. The first FDA enforcement report date is 24 Jun 2020. The record gives the status Terminated, with the termination date 21 Sep 2023.

FDA enforcement report The 15 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden,…

Recalling firm

Stryker GmbH, Selzach, Switzerland.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

15 product records in the event.

FDA event 85681: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2373-2020	Stryker 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.	56 OUS	Class II	Terminated	24 Jun 2020
Z-2374-2020	Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	26 OUS	Class II	Terminated	24 Jun 2020
Z-2375-2020	Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	186 OUS	Class II	Terminated	24 Jun 2020
Z-2376-2020	Stryker End Cap, Standard T2 Humerus 6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	109 OUS	Class II	Terminated	24 Jun 2020
Z-2377-2020	Stryker 1 End Cap T2 Humerus 6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	69 OUS	Class II	Terminated	24 Jun 2020
Z-2378-2020	Stryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	US 3; OUS 2	Class II	Terminated	24 Jun 2020
Z-2379-2020	Stryker Locking Screw, Partially Threaded T2 Tibia 5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	US 3; OUS 13	Class II	Terminated	24 Jun 2020
Z-2380-2020	Stryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	OUS 40	Class II	Terminated	24 Jun 2020
Z-2381-2020	Stryker Locking Screw, Fully Threaded T2 Tibia 5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	US 46; OUS 314	Class II	Terminated	24 Jun 2020
Z-2382-2020	Stryker Locking Screw, Fully Threaded T2 Tibia 5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	OUS: 1404	Class II	Terminated	24 Jun 2020
Z-2383-2020	Stryker Locking Screw, Fully Threaded T2 Tibia 5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	US 76; OUS 290	Class II	Terminated	24 Jun 2020
Z-2384-2020	Stryker Locking Screw, Fully Threaded T2 Tibia 5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	OUS 400	Class II	Terminated	24 Jun 2020
Z-2385-2020	Stryker Locking Screw, Fully Threaded T2 Tibia 5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	US:127; OUS 454	Class II	Terminated	24 Jun 2020
Z-2386-2020	Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	OUS 121	Class II	Terminated	24 Jun 2020
Z-2387-2020	Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.	US 3; OUS 1	Class II	Terminated	24 Jun 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 15Median of the firm: 1
Events of the firm on the register: 21

Other events of the firm

Other FDA enforcement events of Stryker GmbH
Initiated	Product (first record)	Type	Class	Records
1 Jul 2026	Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.	Device	Class II	7
28 May 2025	Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.	Device	Class II	1
22 May 2025	Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.	Device	Class II	2
28 Mar 2025	Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;	Device	Class II	2
9 May 2024	Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.	Device	Class II	1
7 Feb 2023	stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon	Device	Class II	1
28 Mar 2022	Smart Toe II Intramedullary Arthrodesis Implant	Device	Class II	1
27 May 2021	Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S	Device	Class II	2
25 Sep 2020	Osteosynthesis Compression Staple EasyClip	Device	Class II	1
5 Dec 2019	Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertio	Device	Class II	1

Stryker GmbH: all 21 events

Official channels

FDA enforcement report Z-2373-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 85681. https://recallregister.com/fda/ii/85681/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden,…
What quantity of product is in FDA event 85681?: The event has 15 product records. The first record gives this quantity: 56 OUS
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.