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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 29 of 70

Device	Model / Reference	Registries	Class	Status
MobiliT™ Cup	CH-72281	FDA UDI	Class I	Active
APEX Knee System	GM14003-3155-01	FDA UDI	Class I	Active
APEX Knee System	WS-30075	FDA UDI	Class I	Active
OMNI K1 Hip	HC-00100	FDA UDI	Class II	Active
OMNIBotics	4146-1000	FDA UDI	Class II	Active
APEX Revision Knee	KP-4510R	FDA UDI	Class II	Active
APEX Knee System	EP-22214	FDA UDI	Class II	Active
APEX Knee System	KT-4305R	FDA UDI	Class I	Active
APEX Knee System	EP-24124	FDA UDI	Class II	Active
OMNI Interface Acetabular System	HS-61110	FDA UDI	Class I	Active
APEX Knee System	KS-71201	FDA UDI	Class I	Active
APEX Knee System	KP-0455L-HP	FDA UDI	Class II	Active
APEX Revision Knee	KP-0410R	FDA UDI	Class II	Active
APEX Knee System	KS-92613	FDA UDI	Class I	Active
APEX Knee System	WS-30075	FDA UDI	Class I	Active
APEX CR Knee	KC-1410L	FDA UDI	Class II	Active
APEX PS Knee	KP-0060R	FDA UDI	Class II	Active
OMNI Mod Hip	231400	FDA UDI	Class II	Active
OMNI Hip	H3-82855	FDA UDI	Class II	Active
OMNI Interface Acetabular System	410056	FDA UDI	Class II	Active
APEX Knee System	KS-67069	FDA UDI	Class I	Active
APEX Knee System	EC-40290	FDA UDI	Class II	Active
APEX Knee System	KR-45020	FDA UDI	Class I	Active
OMNIBotics	4145-5100	FDA UDI	Class II	Active
OMNIBotics	NS-5041B	FDA UDI	Class I	Active
APEX Knee System	XK-50020	FDA UDI	Class I	Active
APEX Knee System	WS-60010	FDA UDI	Class I	Active
OMNI Interface Acetabular System	414832	FDA UDI	Class II	Active
APEX Knee System	KR-50009	FDA UDI	Class I	Active
OMNIBotics	0113-0000	FDA UDI	Class II	Active
APEX Knee System	XK-5023L	FDA UDI	Class I	Active
OMNIBotics	NS-40130	FDA UDI	Class II	Active
APEX Knee System	XK-03026	FDA UDI	Class I	Active
OMNI Interface Acetabular System	H5-45228	FDA UDI	Class II	Active
APEX Knee System	KS-1455R	FDA UDI	Class I	Active
APEX Knee System	KS-67011	FDA UDI	Class I	Active
APEX Knee System	KS-1425L	FDA UDI	Class I	Active
APEX Knee System	KS-90073	FDA UDI	Class I	Active
APEX Knee System	KS-92112	FDA UDI	Class I	Active
Unity Knee System	CK-72457	FDA UDI	Class I	Active
APEX Knee System	800100	FDA UDI	Class I	Active
OMNI Interface Acetabular System	435228	FDA UDI	Class II	Active
OMNIBotics	NS-40040	FDA UDI	Class II	Active
APEX Knee System	KR-56100	FDA UDI	Class I	Active
APEX Knee System	XK-00233	FDA UDI	Class I	Active
APEX Knee System	GM-03061-06	FDA UDI	Class I	Active
APEX Revision Knee	KC-50250	FDA UDI	Class II	Active
APEX Revision Knee	KP-24216	FDA UDI	Class II	Active
APEX Revision Knee	KP-3105L	FDA UDI	Class II	Active
APEX Knee System	KR-22001	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.