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OMNIlife science, Inc.

United States·US-MF-000015882

Last updated September 17, 2026

Information

Country: United States
Address: 480, Paramount Drive, Raynham, United States
Website: coringroup.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Christina Rovaldi
EUDAMED SRN: US-MF-000015882
FDA FEI Number: 3013682146
DUNS Number: —

Catalogue (3452)

Page 32 of 70

Device	Model / Reference	Registries	Class	Status
OMNI Interface Acetabular System	H4-04432	FDA UDI	Class II	Active
APEX CR Knee	KC-1440R	FDA UDI	Class II	Active
APEX Knee System	KS-91210	FDA UDI	Class I	Active
APEX Knee System	KR-20012	FDA UDI	Class I	Active
APEX Knee System	KR-40250	FDA UDI	Class I	Active
APEX Knee System	KS-81002	FDA UDI	Class I	Active
APEX Knee System	KT-4410L	FDA UDI	Class I	Active
APEX Knee System	KR-54180	FDA UDI	Class I	Active
APEX Knee System	KS-90096-IN	FDA UDI	Class I	Active
OMNI Knee	KC-37041	FDA UDI	Class II	Active
APEX Knee System	KS-94512	FDA UDI	Class I	Active
OMNI ARC Hip	HC-23001-HA	FDA UDI	Class II	Active
APEX Knee System	KS-92320	FDA UDI	Class I	Active
APEX PS Knee	KP-21018	FDA UDI	Class II	Active
APEX Knee System	KR-56260	FDA UDI	Class I	Active
APEX Knee System	KS-99003	FDA UDI	Class I	Active
APEX Knee System	KT-0455L	FDA UDI	Class I	Active
OMNIBotics	NS-5032A	FDA UDI	Class II	Active
APEX Knee System	EP-24510	FDA UDI	Class II	Active
APEX Knee System	KS-70021	FDA UDI	Class I	Active
APEX Knee System	KP-39128	FDA UDI	Class II	Active
K1 Hip Syetem	CK-07108	FDA UDI	Class I	Active
OMNIBotics	NS-S6001	FDA UDI	Class I	Active
APEX Knee System	XK-66021	FDA UDI	Class I	Active
APEX Knee System	XG-80013-21-10	FDA UDI	Class I	Active
OMNI Mod Hip	150902	FDA UDI	Class II	Active
APEX Knee System	WS-2114R	FDA UDI	Class I	Active
OMNI Knee	KC-37040	FDA UDI	Class II	Active
APEX Knee System	KS-61210	FDA UDI	Class I	Active
APEX Knee System	XK-0115R	FDA UDI	Class I	Active
APEX Knee System	GM-03006-10	FDA UDI	Class I	Active
Unity Knee System	CK-11204-01-00	FDA UDI	Class I	Active
APEX Knee System	KR-50165-R	FDA UDI	Class I	Active
Unity Knee System	CK-72194	FDA UDI	Class I	Active
APEX Knee System	KR-50245	FDA UDI	Class I	Active
APEX Knee System	KS-66021A	FDA UDI	Class I	Active
OMNI K1 Hip	HC-00109	FDA UDI	Class II	Active
APEX Knee System	KP-39124	FDA UDI	Class II	Active
OMNIBotics	NS-06996-RH	FDA UDI	Class II	Active
APEX Knee System	KR-21004	FDA UDI	Class I	Active
APEX Knee System	KS-2112R-A	FDA UDI	Class I	Active
TriFit CF Hip System	CH-69679	FDA UDI	Class I	Active
APEX Revision Knee	KP-24511	FDA UDI	Class II	Active
APEX PS Knee	KP-20611	FDA UDI	Class II	Active
APEX Knee System	KS-1465R	FDA UDI	Class I	Active
APEX Knee System	KS-91216	FDA UDI	Class I	Active
APEX CR Knee	KC-1460R	FDA UDI	Class II	Active
APEX Revision Knee	KP-24328	FDA UDI	Class II	Active
OMNI Knee	KC-2404L	FDA UDI	Class II	Active
OMNI Interface Acetabular System	H5-11356	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.