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WRIGHT MEDICAL TECHNOLOGY, INC.

United States·US-MF-000025260

Last updated September 17, 2026

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 5 of 168

Device	Model / Reference	Registries	Class	Status
Ortholoc	58934030	FDA UDI	Class II	Active
Carolina Jones	40112714	FDA UDI	Class II	Active
Prophecy Infinity	33689021	FDA UDI	Class II	Active
Lpt	24872013	FDA UDI	Class I	Active
ORTHOLOC 3Di	58884060	FDA UDI	Class II	Active
Ortholoc 3di	58A0MPX1L	FDA UDI	Class II	Active
Evolve Triad	4942045N	FDA UDI	Class II	Unknown
Evolve	4943536N	FDA UDI	Class II	Unknown
Sidekick	RR20PF	FDA UDI	Class II	Unknown
ORTHOLOC 3Di	5881027012	FDA UDI	Class II	Unknown
Ortholoc	5351035048	FDA UDI	Class II	Active
Darco	777451402	FDA UDI	Class II	Active
Fuseforce	FFNS101513	FDA UDI	Class II	Active
Charlotte	43500023	FDA UDI	Class II	Active
Ortholoc	535S035048	FDA UDI	Class II	Active
Ortholoc	58S34014	FDA UDI	Class II	Active
Rayhack	770	FDA UDI	Class II	Active
Swanson	431001S	FDA UDI	Class II	Active
Evolve	4983524N	FDA UDI	Class II	Active
Ortholoc	58934050	FDA UDI	Class II	Active
Incompass Total Ankle System	33852207	FDA UDI	Class II	Active
Endo-Fuse	500006915	FDA UDI	Class II	Active
Darco	777356002	FDA UDI	Class II	Active
CLAW II ORTHOLOC 3DSi	40240430	FDA UDI	Class II	Active
Darco	77706514	FDA UDI	Class I	Active
Locon-T	49000228	FDA UDI	Class II	Active
Ortholoc	5201024024	FDA UDI	Class II	Active
ORTHOLOC 3DSi	40233550	FDA UDI	Class II	Active
Darco	777404022	FDA UDI	Class II	Active
Crosscheck	CCP-N3516	FDA UDI	Class II	Active
SALVATION 3Di	SP224018	FDA UDI	Class II	Active
Infinity	33630026	FDA UDI	Class II	Active
Charlotte	43513700	FDA UDI	Class I	Active
Inbone	IB205511	FDA UDI	Class II	Active
Ortholoc 3di	58S8701R	FDA UDI	Class II	Active
Evolve	4943512N	FDA UDI	Class II	Unknown
Charlotte	56015565	FDA UDI	Class II	Active
Micronail	59402522	FDA UDI	Class II	Unknown
Rayhack	952	FDA UDI	Class II	Active
ORTHOLOC 3Di	5888102L	FDA UDI	Class II	Active
Made-To-Order	SMS00131	FDA UDI	Class I	Active
Sidekick	RR700035	FDA UDI	Class I	Active
Darco	DCS2825032	FDA UDI	Class II	Unknown
Darco	777453602	FDA UDI	Class II	Active
Darco	DC016105	FDA UDI	Class II	Active
Darco	DCS04346	FDA UDI	Class II	Active
Cannulated Screw System	03-4001-40	FDA UDI	Class II	Active
Biofoam	46602055	FDA UDI	Class I	Active
Made-To-Order	SMS00602	FDA UDI	Class I	Active
Ortholoc 3di Plating System	58882031	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.

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.