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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 7 of 168

Device	Model / Reference	Registries	Class	Status
Darco	777354402	FDA UDI	Class II	Active
Invision	60005000	FDA UDI	Class II	Active
Invision	60002201	FDA UDI	Class I	Active
Infinity	33600140	FDA UDI	Class II	Active
EVOLVE Proline	24981008	FDA UDI	Class I	Active
Dart-Fire	D1N002530	FDA UDI	Class II	Unknown
ORTHOLOC 3Di	58803532	FDA UDI	Class II	Active
Ortholoc	58S23516	FDA UDI	Class II	Active
ORTHOLOC 3Di	59225536	FDA UDI	Class II	Active
Orthosphere	8530013	FDA UDI	Class II	Active
Darco	DC31002034	FDA UDI	Class I	Active
Mdi	74000012	FDA UDI	Class I	Active
Salvation™	SEFA2180	FDA UDI	Class II	Active
Darco	DC31001078	FDA UDI	Class I	Active
ORTHOLOC 3Di	58S40045	FDA UDI	Class II	Active
Osteoset	P0SR3001	FDA UDI	Class II	Unknown
Made-To-Order	SMS00350	FDA UDI	Class I	Active
Swanson	4460100	FDA UDI	Class I	Active
Olympia	2870GC48	FDA UDI	Class II	Active
Hunter	TR500000	FDA UDI	Class I	Active
Invision	60022800	FDA UDI	Class I	Active
ORTHOLOC 3Di	58S50001	FDA UDI	Class II	Active
Sidekick	RR3535180TN	FDA UDI	Class II	Active
Salvation	SB170175	FDA UDI	Class II	Active
Evolve	4943532L	FDA UDI	Class II	Unknown
Phalinx	45301012	FDA UDI	Class II	Active
Tcp System	03-9013-08	FDA UDI	Class II	Unknown
Mica	57S0L122	FDA UDI	Class I	Active
Ortholoc	52021160	FDA UDI	Class I	Active
DartFire Edge	D1135020	FDA UDI	Class II	Active
ORTHOLOC 3Di	58S03516	FDA UDI	Class II	Active
DartFire Edge	D0330044	FDA UDI	Class II	Active
Inbone™ Everlast™	22024320	FDA UDI	Class II	Active
DartFire Edge	D0330026	FDA UDI	Class II	Active
DartFire Edge	D0130050	FDA UDI	Class II	Active
Ortholoc	5201024010	FDA UDI	Class II	Active
Darco	DC31002058	FDA UDI	Class I	Active
Made-To-Order	SMS00494	FDA UDI	Class I	Active
Made-To-Order	SMS00430	FDA UDI	Class I	Active
Ortholoc	58813522	FDA UDI	Class II	Active
Darco	777757062	FDA UDI	Class II	Unknown
Darco	777405502	FDA UDI	Class II	Active
Lmh	62001012	FDA UDI	Class II	Active
Incompass Total Ankle System	33850033	FDA UDI	Class II	Active
Ortholoc	58S13548	FDA UDI	Class II	Active
Dart-Fire	D1N20020S	FDA UDI	Class II	Active
ORTHOLOC 3Di CROSSCHECK	582SX3532	FDA UDI	Class II	Active
ORTHOLOC 3DSi	40233555	FDA UDI	Class II	Active
Ortholoc	5351035016	FDA UDI	Class II	Unknown
Dart-Fire	DSDS1024	FDA UDI	Class I	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.