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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 16 of 70

Device	Model / Reference	Registries	Class	Status
APEX Knee System	WS-60006	FDA UDI	Class I	Active
APEX Knee System	EP-22420	FDA UDI	Class II	Active
OMNI Interface Acetabular System	H5-11050	FDA UDI	Class II	Active
OMNI ARC Hip	HC-22001	FDA UDI	Class II	Active
OMNIBotics	NS-5042A	FDA UDI	Class I	Active
OMNIBotics	4160-5000	FDA UDI	Class II	Active
APEX Knee System	KR-50140	FDA UDI	Class I	Active
APEX Knee System	XK-10064	FDA UDI	Class I	Active
APEX Knee System	XK-00065	FDA UDI	Class I	Active
APEX Knee System	KR-55170	FDA UDI	Class I	Active
APEX Knee System	KC-55103	FDA UDI	Class II	Active
APEX Knee System	KS-44116	FDA UDI	Class I	Active
APEX Knee System	KS-90033	FDA UDI	Class I	Active
APEX Knee System	KR-40150	FDA UDI	Class I	Active
OMNI Mod Hip	230410	FDA UDI	Class II	Active
APEX Knee System	KS-60024	FDA UDI	Class I	Active
APEX Knee System	KT-0415L	FDA UDI	Class I	Active
APEX Knee System	EC-36026	FDA UDI	Class II	Active
APEX Knee System	WS-20076	FDA UDI	Class I	Active
APEX Knee System	WS-40038	FDA UDI	Class I	Active
OMNI Knee	KC-36054	FDA UDI	Class II	Active
APEX Knee System	EP-24318	FDA UDI	Class II	Active
APEX Knee System	XK-06154	FDA UDI	Class I	Active
APEX Knee System	KT-42101	FDA UDI	Class I	Active
APEX Knee System	KS-90092-IN	FDA UDI	Class I	Active
APEX Knee System	KS-44418	FDA UDI	Class I	Active
APEX Knee System	KS-93613	FDA UDI	Class I	Active
APEX Knee System	KS-92213	FDA UDI	Class I	Active
APEX Knee System	WS-20058	FDA UDI	Class I	Active
OMNI Interface Acetabular System	435236	FDA UDI	Class II	Active
APEX Knee System	KS-95128	FDA UDI	Class I	Active
APEX Knee System	GM-03061-17	FDA UDI	Class I	Active
APEX Knee System	KS-60035	FDA UDI	Class I	Active
APEX Knee System	WS-30076	FDA UDI	Class I	Active
APEX Revision Knee	KC-50255	FDA UDI	Class II	Active
APEX Knee System	KR-46030	FDA UDI	Class I	Active
APEX Knee System	KS-90015	FDA UDI	Class I	Active
APEX Knee System	XK-66025	FDA UDI	Class I	Active
APEX Knee System	KS-93220	FDA UDI	Class I	Active
APEX Knee System	EP-20214	FDA UDI	Class II	Active
APEX Knee System	KS-90072	FDA UDI	Class I	Active
APEX Knee System	KS-95120	FDA UDI	Class I	Active
OMNI Hip	H3-82856	FDA UDI	Class II	Active
APEX Knee System	KC-55242	FDA UDI	Class II	Active
APEX Knee System	KS-95420	FDA UDI	Class I	Active
APEX Knee System	XG-80013-21-02	FDA UDI	Class I	Active
APEX Knee System	XK-00230	FDA UDI	Class I	Active
MobiliT™ Cup	CH-72283	FDA UDI	Class I	Active
OMNIBotics	NS-5012R	FDA UDI	Class II	Active
APEX Knee System	KS-90075-IN	FDA UDI	Class I	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.