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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 14 of 70

Device	Model / Reference	Registries	Class	Status
APEX Knee System	KS-99202	FDA UDI	Class I	Active
OMNI K1 Hip	HC-00020	FDA UDI	Class II	Active
APEX Knee System	KS-93211	FDA UDI	Class I	Active
APEX CR Knee	KC-1104L	FDA UDI	Class II	Active
APEX Knee System	KC-27110-HP	FDA UDI	Class II	Active
APEX Knee System	KR-45010-R	FDA UDI	Class I	Active
OMNIBotics	NS-S5002	FDA UDI	Class I	Active
APEX PS Knee	KP-22511	FDA UDI	Class II	Active
OMNI K2 Hip	HC-30090	FDA UDI	Class II	Active
OMNI K2 Hip	130008	FDA UDI	Class II	Active
APEX Knee System	KS-1435L	FDA UDI	Class I	Active
APEX Knee System	KC-1106R-HP	FDA UDI	Class II	Active
APEX Knee System	KP-39118	FDA UDI	Class II	Active
APEX Knee System	WS-60019	FDA UDI	Class I	Active
APEX Knee System	XK-5021L	FDA UDI	Class I	Active
APEX Knee System	XK-68741	FDA UDI	Class I	Active
APEX Revision Knee	KP-42050	FDA UDI	Class II	Active
OMNI Conical Stem	HC-32480	FDA UDI	Class II	Active
APEX Knee System	KT-0020R	FDA UDI	Class I	Active
APEX Knee System	KP-21116	FDA UDI	Class II	Active
APEX Knee System	KC-55223	FDA UDI	Class II	Active
APEX Knee System	XK-70944	FDA UDI	Class I	Active
APEX Knee System	KS-61108	FDA UDI	Class I	Active
APEX Knee System	KR-50007	FDA UDI	Class I	Active
APEX Knee System	KS-94614	FDA UDI	Class I	Active
APEX Knee System	KS-90086-IN	FDA UDI	Class I	Active
APEX Knee System	KS-93620	FDA UDI	Class I	Active
APEX Knee System	KS-93118	FDA UDI	Class I	Active
APEX Knee System	KR-53120	FDA UDI	Class I	Active
Unity Knee System	CK-07246	FDA UDI	Class I	Active
OMNI Interface Acetabular System	H5-44132	FDA UDI	Class II	Active
APEX Knee System	KS-63001	FDA UDI	Class I	Active
APEX Knee System	X780-05	FDA UDI	Class I	Active
APEX Knee System	EP-20118	FDA UDI	Class II	Active
APEX Knee System	KC-53002	FDA UDI	Class II	Active
APEX Knee System	KR-50080	FDA UDI	Class I	Active
APEX Knee System	EP-24311	FDA UDI	Class II	Active
APEX Knee System	KS-99022	FDA UDI	Class I	Active
APEX Knee System	KR-71310	FDA UDI	Class I	Active
APEX Knee System	KR-52110	FDA UDI	Class I	Active
APEX Knee System	EP-20512	FDA UDI	Class II	Active
APEX Knee System	KT-0410L	FDA UDI	Class I	Active
APEX Knee System	KR-56220	FDA UDI	Class I	Active
APEX Knee System	KS-92518	FDA UDI	Class I	Active
APEX Knee System	EP-22216	FDA UDI	Class II	Active
APEX Knee System	EC-36052	FDA UDI	Class II	Active
APEX Knee System	KP-0445L-HP	FDA UDI	Class II	Active
APEX Revision Knee	KC-52772	FDA UDI	Class II	Active
APEX Knee System	KR-50000	FDA UDI	Class I	Active
APEX Knee System	KT-08002	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.