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STRYKER Communications, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 571 Silveron Blvd., Flower Mound, TX, 75028
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002975342
DUNS Number: —

Catalogue (52)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Operon	OZ 7550275	FDA UDI	Class I	Active
Operon	OZ 7552075	FDA UDI	Class I	Unknown
Operon	OZ 7568875	FDA UDI	Class I	Unknown
SwitchPoint Infinity, iSuite	0678003000	FDA UDI	Class II	Active
StrykeCam	P45000	FDA UDI	Class I	Active
Switchpoint Infinity	0678001400	FDA UDI	Class II	Active
Operon	OZ 7549075	FDA UDI	Class I	Active
Visum	0682001252	FDA UDI	Class II	Active
S-Series	0682400550	FDA UDI	Class I	Active
Operon	OZ 7548475	FDA UDI	Class I	Active
StrykeCam	P36000	FDA UDI	Class I	Active
Visum	0682400138	FDA UDI	Class II	Active
Operon	OZ 7552475	FDA UDI	Class I	Unknown
Operon	OZ 7550075	FDA UDI	Class I	Active
Visum Blade, iSuite	P22309	FDA UDI	Class II	Active
Operon	OZ 7549875	FDA UDI	Class I	Active
Operon	OZ 7527675	FDA UDI	Class I	Active
Visum	0682400137	FDA UDI	Class II	Active
Operon	OZ 7551875	FDA UDI	Class I	Active
Operon	OZ 7551075	FDA UDI	Class I	Active
Operon	OZ 7552875	FDA UDI	Class I	Active
Operon	OZ 7548875	FDA UDI	Class I	Active
Operon	OZ 7548275	FDA UDI	Class I	Active
Operon	OZ 7569075	FDA UDI	Class I	Unknown
Operon	OZ 7550675	FDA UDI	Class I	Active
Operon	OZ 7551675	FDA UDI	Class I	Active
Operon	OZ 7551275	FDA UDI	Class I	Active
Operon	OZ 7552275	FDA UDI	Class I	Unknown
Visum	0682001253	FDA UDI	Class II	Active
Flexis	0682400500	FDA UDI	Class I	Active
Operon	OZ 7518475	FDA UDI	Class I	Active
Visum Blade	P22310	FDA UDI	Class II	Active
Operon	OZ 7554275	FDA UDI	Class I	Active
Operon	OZ 7553075	FDA UDI	Class I	Active
Operon	OZ 7561075	FDA UDI	Class I	Unknown
Operon	OZ 7550875	FDA UDI	Class I	Active
Operon	OZ 7559275	FDA UDI	Class I	Active
SwitchPoint Infinity, iSuite	0678001000	FDA UDI	Class II	Active
In-Light Camera	P59109	FDA UDI	Class I	Active
Operon	OZ 7548675	FDA UDI	Class I	Active
Operon	OZ 7549475	FDA UDI	Class I	Active
Operon	OZ 7555775	FDA UDI	Class I	Active
Operon	OZ 7549675	FDA UDI	Class I	Active
Operon	OZ 7580275	FDA UDI	Class I	Active
Operon	OZ 7549275	FDA UDI	Class I	Active
Operon	OZ 7552675	FDA UDI	Class I	Active
Operon	OZ 7559375	FDA UDI	Class I	Active
Operon	OZ 7522875	FDA UDI	Class I	Active
Visum Led Surgical Lighting System	K060802	FDA 510(k)	Class II	Active
Visum Blade Led Surgical Lighting System	K132747	FDA 510(k)	Class II	Active

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FDA Recalls (47)

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
Feb 23, 2026	Z-1688-2026	—	open, classified	Surgical light assembly may not adequate support the weight of the ceiling cover.
Jul 15, 2025	Z-2620-2025	—	open, classified	Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Feb 8, 2024	Z-1506-2024	—	open, classified	Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
Jan 29, 2021	Z-1297-2021	—	open, classified	The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.
Oct 11, 2019	Z-1602-2020	—	terminated	The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.
Aug 1, 2019	Z-2446-2019	—	terminated	The mounts on the monitor may have an insufficient weld.
Mar 22, 2019	Z-2540-2019	—	open, classified	The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Mar 22, 2019	Z-2539-2019	—	open, classified	The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Nov 13, 2018	Z-1388-2019	—	open, classified	There is a potential the joint in the suspension of the device is insufficiently assembled.
Jan 29, 2018	Z-0828-2018	—	terminated	The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
Jan 26, 2018	Z-0692-2018	—	terminated	The mounts on the monitor may have an insufficient (missing or incomplete) weld.
Apr 21, 2017	Z-2248-2017	—	terminated	The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
Feb 28, 2017	Z-1699-2017	—	terminated	The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
Mar 17, 2014	Z-2052-2014	—	terminated	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Mar 17, 2014	Z-2053-2014	—	terminated	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Mar 17, 2014	Z-2056-2014	—	terminated	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Mar 17, 2014	Z-2054-2014	—	terminated	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Mar 17, 2014	Z-2055-2014	—	terminated	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
Jul 25, 2013	Z-1992-2013	—	terminated	Potential incomplete final weld on the drop tube flange.
Sep 25, 2012	Z-0657-2013	—	terminated	Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or monitors mounted to the end of the Spring Arm. To date, there have been no serious injuries reported from the incomplete e
Nov 7, 2011	Z-0913-2012	—	terminated	Stryker has identified a potential structural issue with the Visum LED surgical light(s). During a complaint investigation, Stryker became aware that there was a possibility that incorrect assembly could result in the light head beginning to separate from the suspension arm. In the event the light separates and falls from the arm, it could lead to serious injury.
Aug 23, 2011	Z-0136-2012	—	terminated	Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
Aug 23, 2011	Z-0137-2012	—	terminated	Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
Aug 23, 2011	Z-0138-2012	—	terminated	Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
Jan 28, 2011	Z-1611-2011	—	terminated	Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product.
Apr 30, 2010	Z-1803-2010	—	terminated	Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a frozen touch panel.
Apr 15, 2010	Z-1642-2010	—	terminated	Installation records are incomplete.
Apr 15, 2010	Z-1643-2010	—	terminated	Installation records are incomplete.
Apr 15, 2010	Z-1640-2010	—	terminated	Installation records are incomplete.
Apr 15, 2010	Z-1645-2010	—	terminated	Installation records are incomplete.
Apr 15, 2010	Z-1644-2010	—	terminated	Installation records are incomplete.
Apr 15, 2010	Z-1641-2010	—	terminated	Installation records are incomplete.
Apr 7, 2010	Z-1605-2010	—	terminated	Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
Nov 13, 2009	Z-1238-2010	—	terminated	In certain positions, product is susceptible to fluid instrusion which could possibly result in short circuit or unsolicited movement.
May 19, 2009	Z-1569-2009	—	terminated	Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.
May 8, 2009	Z-1418-2009	—	terminated	Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.
Nov 13, 2008	Z-1899-2009	—	terminated	Surgical tables were produced using an unapproved tilt frame bushing.
Sep 5, 2008	Z-0182-2009	—	terminated	Circlip component used to suspend flat panel and navigation arm system may become dislodged.
Sep 2, 2008	Z-0625-2009	—	terminated	Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. For further information, please contact Stryker Communications Corporation by telephone at 97
Jul 2, 2008	Z-2376-2008	—	terminated	Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
Jul 2, 2008	Z-2379-2008	—	terminated	Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
Jul 2, 2008	Z-2377-2008	—	terminated	Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
Jul 2, 2008	Z-2378-2008	—	terminated	Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
May 1, 2008	Z-2189-2008	—	terminated	Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on VERTIER Surgical Table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
Apr 1, 2008	Z-2467-2008	—	terminated	Product at times experiences intermittent signal loss due to electromagnetic interference.
Oct 3, 2007	Z-0303-2008	—	terminated	Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.
Oct 3, 2007	Z-0302-2008	—	terminated	Intermitten or Complete Loss of Signal: out-of-specification DVI cables causing intermitten or complete loss of signal on monitors used in surgery.