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WRIGHT MEDICAL TECHNOLOGY, INC.

United States·US-MF-000025260

Last updated September 17, 2026

What WRIGHT MEDICAL TECHNOLOGY, INC. makes

The company manufactures orthopaedic bone screws, including non-bioabsorbable and non-sterile variants, as well as non-sliding types for surgical fixation. It also produces fixed-bearing total ankle prostheses, reusable surgical implant templates, and ankle prosthesis trials. Orthopaedic fixation plates, both non-bioabsorbable and non-sterile, are part of its portfolio, alongside specific device examples like the Incompass Total Ankle System and TCP.

These devices are regulated under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Wright Medical Technology, Inc. manufacture?

Wright Medical Technology, Inc. specializes in orthopaedic devices, including non-bioabsorbable bone screws (both sterile and non-sterile), non-sliding bone screws, and orthopaedic fixation plates. It also produces fixed-bearing total ankle prostheses like the Incompass Total Ankle System, reusable surgical implant templates, and ankle prosthesis trials. These devices are designed for surgical fixation and joint replacement applications.

Where is Wright Medical Technology, Inc. based?

The company is headquartered in the United States. Its location is relevant for regulatory oversight, as it operates under FDA jurisdiction for its devices.

Which regulatory registries or databases list Wright Medical Technology, Inc.’s devices?

Wright Medical Technology, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for orthopaedic implants like bone screws, fixation plates, and ankle prostheses.

How are Wright Medical Technology, Inc.’s devices classified under FDA regulations?

The company’s devices fall under FDA Class I and Class II classifications. Class I typically includes low-risk devices like some orthopaedic screws, while Class II covers moderate-risk items such as fixed-bearing ankle prostheses or fixation plates, which require additional validation for safety and performance.

What distinguishes Wright Medical Technology, Inc.’s orthopaedic devices from others in the market?

Wright Medical Technology, Inc. focuses on both foundational hardware (e.g., bone screws and plates) and advanced joint replacements (e.g., the Incompass Total Ankle System). Its portfolio blends reusable surgical tools like implant templates with permanent implants, catering to precision fixation and joint restoration needs in orthopaedic surgery.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 11500, Memphis-Arlington Road, Tennessee, United States
Website: www.stryker.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +41 (0)32 641 6666
PRRC Contact: Jeanine Redden
EUDAMED SRN: US-MF-000025260
FDA FEI Number: 1043534
DUNS Number: 807201207

Catalogue (8357)

Page 12 of 168

Device	Model / Reference	Registries	Class	Status
Hunter	ATDC2040	FDA UDI	Class II	Active
Dart-Fire	D1N35028S	FDA UDI	Class II	Active
Cannulated Screw System	03-4002-10	FDA UDI	Class II	Active
Ortholoc 3di	58A12718	FDA UDI	Class II	Active
Darco	DCS2832027	FDA UDI	Class II	Active
Darco	DC2801122	FDA UDI	Class II	Active
Invision	60002801	FDA UDI	Class II	Active
Salvation™	SEF11160	FDA UDI	Class II	Active
ORTHOLOC 3Di	58S03534	FDA UDI	Class II	Active
Evolve	4943560L	FDA UDI	Class II	Unknown
SALVATION 3Di	SP224060	FDA UDI	Class II	Active
Ortholoc 3di	52031316	FDA UDI	Class I	Active
Valor	4150002350	FDA UDI	Class I	Active
Swanson	4460103	FDA UDI	Class I	Active
Infinity™ Everlast™	33685506	FDA UDI	Class II	Active
DartFire Edge	D0240012	FDA UDI	Class II	Active
DartFire Edge	D0130028	FDA UDI	Class II	Active
Infinity	33603308	FDA UDI	Class I	Active
SALVATION 3Di	SP235532	FDA UDI	Class II	Active
Infinity	33624311	FDA UDI	Class I	Active
Inbone	IB282904	FDA UDI	Class II	Active
Tcp	08-924N	FDA UDI	Class I	Active
Infinity	33600434	FDA UDI	Class II	Active
Ortholoc 3di	58S85030	FDA UDI	Class II	Active
Charlotte	40119005	FDA UDI	Class II	Active
Tcp	03-9006-24	FDA UDI	Class II	Active
Locon-T	24900018	FDA UDI	Class II	Active
Evolve	496H022	FDA UDI	Class II	Active
Coretrak	EFSR5001	FDA UDI	Class I	Active
Hv Screw System	DHVN3020	FDA UDI	Class II	Active
Crosscheck	CCP-LPX2L	FDA UDI	Class II	Active
Evolve	2498H420	FDA UDI	Class I	Active
Pro-Toe	45719011	FDA UDI	Class I	Active
Inbone	200336	FDA UDI	Class I	Active
Hunter	AT204000	FDA UDI	Class II	Active
ORTHOLOC 3DSi CLAW II	402S0425	FDA UDI	Class II	Active
Evolve	24900040	FDA UDI	Class I	Active
Inbone	100063102	FDA UDI	Class I	Active
Phalinx	45303055	FDA UDI	Class I	Active
Sidekick	RR3031	FDA UDI	Class I	Active
Infinity	33653212	FDA UDI	Class II	Active
Salvation	SEF07188	FDA UDI	Class II	Active
Metal Hemi	03-6000-17	FDA UDI	Class II	Active
Ortholoc	58S12730	FDA UDI	Class II	Active
Evolve	4933516L	FDA UDI	Class II	Unknown
Evolve	497H426	FDA UDI	Class II	Unknown
Inbone	220222212E	FDA UDI	Class II	Active
Locon-T	49000SML	FDA UDI	Class II	Active
Valor	4150001014	FDA UDI	Class I	Active
Biofoam	47S52212	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Stryker European Operations Limited IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Wright Medical Technology, Inc. has 140 recall records initiated between August 18, 2003, and March 6, 2024, with statuses recorded as open, classified, or terminated. The reasons cited include potential particulate debris from packaging, missing components in assembled products, dimensional discrepancies in devices, incorrect labeling of dates or specifications, inadequate sterility documentation, and deviations in hardware design or assembly, such as improperly marked plates, missing drivers, or incomplete packaging.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 6, 2024	Z-1477-2024	—	open, classified	Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
Jun 13, 2023	Z-2105-2023	—	open, classified	The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Apr 10, 2023	Z-1467-2023	—	open, classified	Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Apr 10, 2023	Z-1466-2023	—	open, classified	Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Feb 2, 2023	Z-1170-2023	—	open, classified	Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
Feb 2, 2023	Z-1169-2023	—	open, classified	Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
Sep 30, 2022	Z-0140-2023	—	open, classified	The tibial tray lock detail is oversized (larger than specification).
Sep 30, 2022	Z-0139-2023	—	open, classified	The tibial tray lock detail is oversized (larger than specification).
Aug 3, 2022	Z-0005-2023	—	open, classified	The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Aug 3, 2022	Z-0006-2023	—	open, classified	The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
Jul 27, 2022	Z-1567-2022	—	open, classified	An incorrect sizing label was applied to the carton packaging.
Jun 14, 2022	Z-1366-2022	—	open, classified	The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
Jun 2, 2022	Z-1291-2022	—	open, classified	The instrument is incorrectly color coded.
Mar 10, 2022	Z-0853-2022	—	terminated	The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Feb 15, 2022	Z-0786-2022	—	terminated	An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
Feb 9, 2022	Z-0679-2022	—	terminated	Product was labelled with the incorrect manufacturing and distribution dates.
Dec 3, 2021	Z-0401-2022	—	open, classified	Incorrect product is contained in the packaging.
Dec 3, 2021	Z-0393-2022	—	open, classified	The incorrect product is contained in the packaging.
Dec 3, 2021	Z-0392-2022	—	open, classified	The incorrect product is contained in the packaging.
Nov 4, 2021	Z-0315-2022	—	terminated	The package contents and package labeling do not match.
Nov 4, 2021	Z-0316-2022	—	terminated	The package contents and package labeling do not match.
Aug 26, 2020	Z-2989-2020	—	terminated	Lack of sterility assurance
Jul 28, 2020	Z-2797-2020	—	terminated	Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Jul 28, 2020	Z-2796-2020	—	terminated	Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Apr 9, 2020	Z-1924-2020	—	terminated	One lot of INBONE Tibial Trays is missing the plasma coating.
Dec 27, 2019	Z-1101-2020	—	terminated	Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Dec 27, 2019	Z-1102-2020	—	terminated	Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Mar 14, 2018	Z-1376-2018	—	terminated	Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Mar 14, 2018	Z-1375-2018	—	terminated	Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Nov 8, 2016	Z-0563-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0566-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0570-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0572-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0568-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0569-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0564-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0573-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0571-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0567-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0565-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Nov 8, 2016	Z-0562-2020	—	terminated	The firm discovered a lack of adequate documentation confirming sterility on certain products.
Jul 21, 2015	Z-2542-2015	—	terminated	These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
Jul 21, 2015	Z-2541-2015	—	terminated	These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
Apr 16, 2015	Z-1627-2015	—	terminated	The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Apr 16, 2015	Z-1625-2015	—	terminated	The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Apr 16, 2015	Z-1626-2015	—	terminated	The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Apr 16, 2015	Z-1624-2015	—	terminated	The term DORSAL was laser etched on the incorrect side on some of the angled handles.
Mar 6, 2015	Z-1499-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
Mar 6, 2015	Z-1495-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1483-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
Mar 6, 2015	Z-1488-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1497-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1498-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1494-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1487-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1500-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
Mar 6, 2015	Z-1485-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1491-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1486-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1496-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1482-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
Mar 6, 2015	Z-1489-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1490-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1492-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1484-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Mar 6, 2015	Z-1493-2015	—	terminated	The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Jul 30, 2014	Z-2599-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2607-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2604-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2608-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2602-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2601-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2603-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2600-2014	—	terminated	Plates manufactured from an incorrect raw material.
Jul 30, 2014	Z-2605-2014	—	terminated	Plates manufactured from an incorrect raw material.
Sep 5, 2012	Z-0183-2013	—	terminated	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Sep 5, 2012	Z-0184-2013	—	terminated	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Sep 5, 2012	Z-0185-2013	—	terminated	There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Apr 5, 2012	Z-1484-2012	—	terminated	The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Apr 5, 2012	Z-1485-2012	—	terminated	The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Jan 3, 2012	Z-1019-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1017-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1028-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1016-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1022-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1024-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1031-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1021-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1018-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1023-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1025-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1030-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1026-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1027-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1020-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Jan 3, 2012	Z-1029-2012	—	terminated	The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
Sep 20, 2011	Z-0065-2012	—	terminated	The product is labeled with an expiration date without adequate justification.
Sep 20, 2011	Z-0066-2012	—	terminated	The product is labeled with an expiration date without adequate justification.
Sep 20, 2011	Z-0060-2012	—	terminated	The product is labeled with an expiration date without adequate justification.
Sep 20, 2011	Z-0067-2012	—	terminated	The product is labeled with an expiration date without adequate justification.