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OMNIlife science, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 880 N McCarthy Blvd, Milpitas, CA, 95035
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3013682146
DUNS Number: —

Catalogue (3452)

Page 1 of 70

Device	Model / Reference	Registries	Class	Status
APEX Knee System	KS-92120	FDA UDI	Class I	Active
APEX Knee System	X744-00	FDA UDI	Class I	Active
APEX Knee System	WS-40050	FDA UDI	Class I	Active
OMNI Knee	KC-35056	FDA UDI	Class II	Active
APEX Knee System	XK-00101	FDA UDI	Class I	Active
OMNIBotics	4148-1001	FDA UDI	Class II	Active
APEX Revision Knee	KC-50235	FDA UDI	Class II	Active
APEX Knee System	EP-20316	FDA UDI	Class II	Active
APEX Knee System	KP-0065L-HP	FDA UDI	Class II	Active
APEX Revision Knee	KC-52502	FDA UDI	Class II	Active
APEX Revision Knee	KC-52752	FDA UDI	Class II	Active
APEX Revision Knee	KP-4305L	FDA UDI	Class II	Active
OMNI Knee	KC-2304L	FDA UDI	Class II	Active
APEX Knee System	GM-03005-07	FDA UDI	Class I	Active
APEX Knee System	XK-00228	FDA UDI	Class I	Active
Unity Knee System	CK-72198	FDA UDI	Class I	Active
APEX Knee System	KP-20513	FDA UDI	Class II	Active
APEX Knee System	XK-03035	FDA UDI	Class I	Active
APEX Knee System	XK80001	FDA UDI	Class I	Active
APEX Knee System	KR-50001	FDA UDI	Class I	Active
APEX Knee System	KC-55161	FDA UDI	Class II	Active
APEX Knee System	KT-0010R	FDA UDI	Class I	Active
APEX Revision Knee	KP-0415L	FDA UDI	Class II	Active
OMNI Interface Acetabular System	H5-54436	FDA UDI	Class II	Active
OMNIBotics	NV-LPT04	FDA UDI	Class II	Active
APEX Knee System	XK-00081	FDA UDI	Class I	Active
APEX Knee System	XK-00022	FDA UDI	Class I	Active
APEX Knee System	101GS901A050032	FDA UDI	Class I	Active
APEX Knee System	KS-9011L	FDA UDI	Class I	Active
APEX Knee System	EP-24320	FDA UDI	Class II	Active
APEX Knee System	KS-92513	FDA UDI	Class I	Active
APEX Knee System	KC-1465L	FDA UDI	Class II	Active
APEX Knee System	KS-71010	FDA UDI	Class I	Active
APEX Knee System	EP-22614	FDA UDI	Class II	Active
APEX Knee System	KR-46040	FDA UDI	Class I	Active
APEX Knee System	KR-55120	FDA UDI	Class I	Active
APEX Knee System	WS-10099	FDA UDI	Class I	Active
OMNI Interface Acetabular System	415228	FDA UDI	Class II	Active
APEX Revision Knee	KC-50135	FDA UDI	Class II	Active
APEX Knee System	KS-40328	FDA UDI	Class I	Active
OMNI Knee	KC-36062	FDA UDI	Class II	Active
APEX CR Knee	KC-1425R	FDA UDI	Class II	Active
OMNI Hip	333699	FDA UDI	Class II	Active
OMNI Interface Acetabular System	413728	FDA UDI	Class II	Active
APEX Knee System	KP-31101	FDA UDI	Class II	Active
APEX Knee System	XK-0116R	FDA UDI	Class I	Active
APEX Knee System	K7-00103	FDA UDI	Class I	Active
APEX Knee System	WS-60011	FDA UDI	Class I	Active
APEX Knee System	KC-1155L	FDA UDI	Class II	Active
APEX Revision Knee	KP-3115L	FDA UDI	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
Oct 1, 2021	Z-0237-2022	—	terminated	The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Dec 21, 2020	Z-0922-2021	—	terminated	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Dec 21, 2020	Z-0921-2021	—	terminated	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Dec 21, 2020	Z-0920-2021	—	terminated	Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
Sep 11, 2019	Z-0169-2020	—	terminated	Stems missing porous coating on the device.
Jul 23, 2019	Z-2479-2019	—	terminated	Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Jul 23, 2019	Z-2481-2019	—	terminated	Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Jul 23, 2019	Z-2480-2019	—	terminated	Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Apr 12, 2019	Z-1717-2019	—	terminated	The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
Nov 29, 2018	Z-0837-2019	—	terminated	There is a potential for the inner pin of the handle to become loose and fall out.
May 18, 2018	Z-2540-2018	—	terminated	The Internal packaging, the pouch and patient labels are improperly labeled.
Nov 20, 2017	Z-1117-2018	—	terminated	The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
Oct 14, 2016	Z-0610-2017	—	terminated	Incorrect lot number on outer kit
Jun 9, 2015	Z-2455-2015	—	terminated	The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Jun 9, 2015	Z-2454-2015	—	terminated	The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Jun 4, 2015	Z-2445-2015	—	terminated	The device may have improper screw hole placement due to inaccurate location of the index line.
Jun 3, 2015	Z-2064-2015	—	terminated	Product may breach the inner and outer sterile pouches during shipping or handling.
May 9, 2014	Z-2241-2014	—	terminated	Staining on hip implant.
Aug 9, 2012	Z-2373-2012	—	terminated	The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Aug 9, 2012	Z-2374-2012	—	terminated	The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Aug 9, 2012	Z-2371-2012	—	terminated	The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Aug 9, 2012	Z-2372-2012	—	terminated	The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Aug 9, 2012	Z-2370-2012	—	terminated	The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Aug 9, 2012	Z-2375-2012	—	terminated	The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Jul 10, 2009	Z-1988-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1969-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1972-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1984-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1986-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1975-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1987-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1973-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1983-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1978-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1985-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1971-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1967-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1980-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1968-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1976-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1966-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1981-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1982-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1974-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1970-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1979-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Jul 10, 2009	Z-1977-2009	—	terminated	The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.