Stryker Corp.
United Statesfrom the FDA registration address FDA FEI 1811755
Part of Stryker GmbH
Stryker Corp. is a medical device manufacturer, with 14,690 devices listed and 683 FDA recalls as of 14 Nov 2026.
- Devices
- 14,690
- Registrations
- FDA
- FDA recalls
- 683104 ongoing since 2021 (108 open in total)
Registry facts
- Registries
- FDA GUDID 2,998
- EUDAMED 1,474
- FDA 510(k) 2
- Device classes
- FDA Class II 1,791
- FDA Class I 1,126
- FDA Unclassified 49
- FDA Class III 29
- FDA recalls
- Sites and related companies
- Identifiers
- FDA FEI 1811755
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Stryker Corp. makes
Stryker Corp. manufactures orthopaedic hardware including non-sliding bone screws, intramedullary nails for femur fixation, and non-bioabsorbable fixation plates. Their portfolio also includes reusable instrument trays, spinal fixation systems with non-bioabsorbable screws and rods, and external orthopaedic fixation devices. Reusable bone-awls are part of their surgical tool offerings.
The company’s devices are regulated under FDA classifications, including Class I, Class II, and Class III, and are listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 14,690 devicesShowing 1-50 of 14,690
Company details
- FDA FEI number
- 1811755
- Address
- 4100 EAST MILHAM AVE., KALAMAZOO, MI, 49001
FDA recalls
FDA recall records list 192 recalls initiated by Stryker Corp., the earliest on 2016-04-12 and the most recent on 2026-07-01. By recorded status: 108 ongoing, 73 terminated and 11 with another status. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, packaging, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 21
- 2018 37
- 2019 31
- 2020 24
- 2021 3
- 2022 3
- 2023 45
- 2024 22
- 2025 28
- 2026 15
2026
- 1 Jul 2026 Z-2827-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 1 Jul 2026 Z-2828-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 1 Jul 2026 Z-2829-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 1 Jul 2026 Z-2830-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 1 Jul 2026 Z-2831-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 1 Jul 2026 Z-2832-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 1 Jul 2026 Z-2833-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
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- 8 Jun 2026 Z-2862-2026 Class II Ongoing There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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- 8 Jun 2026 Z-2863-2026 Class II Ongoing There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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- 8 Jun 2026 Z-2864-2026 Class II Ongoing There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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- 1 Jul 2026 Z-2827-2026 Class II Ongoing Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Show the 25 most recent of 683 recalls
2026
- 8 Jun 2026 Z-2865-2026 Class II Ongoing There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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- 8 Jun 2026 Z-2866-2026 Class II Ongoing There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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- 6 May 2026 Z-2282-2026 Class II Ongoing It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
- 9 Apr 2026 Z-2166-2026 Class II Ongoing Due to nonconforming products being inadvertently distributed.
- 21 Jan 2026 Z-1427-2026 Class II Ongoing Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
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- 8 Jun 2026 Z-2865-2026 Class II Ongoing There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
2025
- 31 Oct 2025 Z-0599-2026 Class II Ongoing Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
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- 31 Oct 2025 Z-0600-2026 Class II Ongoing Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
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- 31 Oct 2025 Z-0601-2026 Class II Ongoing Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
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- 2 Jul 2025 Z-2277-2025 Class II Ongoing Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
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- 18 Jun 2025 Z-2170-2025 Class II Ongoing Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
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- 18 Jun 2025 Z-2171-2025 Class II Ongoing Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
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- 28 May 2025 Z-1914-2025 Class II Ongoing Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
- 22 May 2025 Z-1939-2025 Class II Ongoing Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
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- 22 May 2025 Z-1940-2025 Class II Ongoing Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
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- 28 Mar 2025 Z-1620-2025 Class II Ongoing The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
- 31 Oct 2025 Z-0599-2026 Class II Ongoing Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
Frequently asked questions
How many devices does Stryker Corp. have in the registry?
The registry currently lists 14690 devices for Stryker Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stryker Corp.'s devices?
Among its 50 most recently registered devices, Stryker Corp. has devices listed in EUDAMED (8 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Stryker Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Stryker Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Stryker Corp.?
FDA recall records list 683 recalls initiated by Stryker Corp., the most recent initiated on 1 Jul 2026. 108 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Stryker Corp. in the registry?
The most recently registered devices listed for Stryker Corp. include Excelsior Reach MC17PSJ155-01, Excelsior Reach MC17PS90155-01, Excelsior Reach MC17PS45165-01 and Excelsior Reach MC17ST155-01.