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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 (8358)

Page 3 of 168

Device	Model / Reference	Registries	Class	Status
Inbone™ Biofoam™ 3d	220221902	FDA UDI	Class II	Active
Charlotte	41113012	FDA UDI	Class II	Active
Infinity	33602210	FDA UDI	Class I	Active
ORTHOLOC 3DSi	403S3524	FDA UDI	Class II	Active
Mica Screw System	57734032	FDA UDI	Class II	Active
Cannulated Screw System	03-4002-18	FDA UDI	Class II	Active
Ortholoc	520S024010	FDA UDI	Class II	Active
ORTHOLOC 3Di	58803538	FDA UDI	Class II	Active
Inbone	200541004	FDA UDI	Class I	Active
Infinity	33651112	FDA UDI	Class II	Active
ORTHOLOC 3Di	59215535	FDA UDI	Class II	Unknown
Darco	DCS2805001	FDA UDI	Class II	Active
Cannulated Screw System	03-4004-26	FDA UDI	Class II	Active
PROstep™ TBC	97700016	FDA UDI	Class I	Active
Claw Ii	402S50020	FDA UDI	Class I	Active
Darco	98200027	FDA UDI	Class I	Active
ORTHOLOC™ 2 Jones Fracture System	56035535	FDA UDI	Class II	Active
Darco	DC2801006	FDA UDI	Class II	Active
Salvation	SEF07145	FDA UDI	Class II	Active
Ortholoc	520S020012	FDA UDI	Class II	Active
Swanson	482303L	FDA UDI	Class II	Active
Charlotte	44110003	FDA UDI	Class II	Active
Ortholoc	58S34016	FDA UDI	Class II	Active
Inbone	200223211E	FDA UDI	Class II	Active
Charlotte	44176016	FDA UDI	Class II	Active
Prostep	HVS03026	FDA UDI	Class II	Active
Darco	DCS2820124	FDA UDI	Class II	Active
Incompass Total Ankle System	33855508	FDA UDI	Class II	Active
ORTHOLOC™ 2 Jones Fracture System	56026550	FDA UDI	Class II	Active
Salvation	SEF99602	FDA UDI	Class I	Active
Inbone	IB282903	FDA UDI	Class II	Active
Swanson	64800100	FDA UDI	Class I	Active
Tcp	07-208	FDA UDI	Class II	Active
Darco	DCS01660	FDA UDI	Class II	Active
Tie-In	28563001	FDA UDI	Class I	Active
Incompass Total Ankle System	33822206	FDA UDI	Class I	Active
PROstep MIS Arthrodesis	58SC4016	FDA UDI	Class I	Active
Biofoam	46650001	FDA UDI	Class I	Active
Osteoset	84000310	FDA UDI	Class II	Active
Darco	DCS04314	FDA UDI	Class II	Active
Darco	777454222	FDA UDI	Class II	Active
Crosscheck	CCP-L3530	FDA UDI	Class II	Active
Dart-Fire	D1N40038S	FDA UDI	Class II	Active
Darco	DC2835001R	FDA UDI	Class II	Active
DartFire Edge	D1240014	FDA UDI	Class II	Active
Darco	DC2806110	FDA UDI	Class II	Active
PROstep™ TBC	97700013	FDA UDI	Class I	Active
Dart-Fire	DSDS0030S	FDA UDI	Class I	Active
Darco	DC2832027	FDA UDI	Class II	Active
Mica	57700001	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.