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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 69 of 70

Device	Model / Reference	Registries	Class	Status
OMNIBotics	NS-5036A	FDA UDI	Class II	Active
Unity Knee System	CK-71013	FDA UDI	Class I	Active
Unity Knee System	CK-71493	FDA UDI	Class I	Active
OMNIBotics	NS-27003	FDA UDI	Class II	Active
OMNIBotics	NS-S1005	FDA UDI	Class I	Active
OMNI K2 Hip	130011	FDA UDI	Class II	Active
OMNIBotics	NS-40150	FDA UDI	Class II	Active
OMNIBotics	NV-CAS01	FDA UDI	Class II	Active
OMNI Mod Hip	230605	FDA UDI	Class II	Active
OMNI Mod Hip	231610	FDA UDI	Class II	Active
Unity Knee System	CK-11204-01-20	FDA UDI	Class I	Active
OMNIBotics	NS-5057B	FDA UDI	Class I	Active
OMNIBotics	XK-67451	FDA UDI	Class I	Active
OMNIBotics	NS-27007	FDA UDI	Class II	Active
Unity Knee System	CK-11204-00-40	FDA UDI	Class I	Active
OMNIBotics	NS-300T4-AL	FDA UDI	Class II	Active
OMNIBotics	9-144	FDA UDI	Class II	Active
OMNIBotics	NV-CRT05	FDA UDI	Class II	Active
OMNIBotics	NS-5011L	FDA UDI	Class II	Active
Unity Knee System	CK-71901	FDA UDI	Class I	Active
OMNI Mod Hip	151606	FDA UDI	Class II	Active
OMNIBotics	NS-5054A	FDA UDI	Class I	Active
APEX CR Knee	KC-1445L	FDA UDI	Class II	Active
Unity Knee System	CK-72195	FDA UDI	Class I	Active
Apex Knee System, Apex All Poly Tibia	K111062	FDA 510(k)	Class II	Active
Apex Knee System	K201611	FDA 510(k)	Class II	Active
OMNI Skirted Heads	K152919	FDA 510(k)	Class II	Active
Apex K1 Hip Stem	K110947	FDA 510(k)	Class II	Active
Apex-Lnk Acetabular Insert, E, Apex-Lnk Acetabular Insert, F, Apex-Lnk	K100555	FDA 510(k)	Class II	Active
OMNI Anseris Hip Stem	K171156	FDA 510(k)	Class II	Active
Apex Knee System, Model Kc-230xy, Kc-240xy [ No Holes, 2 Holes]	K080842	FDA 510(k)	Class II	Active
Apex Hcla Acetabular Cup Liners	K062489	FDA 510(k)	Class II	Active
Apex Module Hip System Biolox Delta Femoral Head	K101451	FDA 510(k)	Class II	Active
Apex Revision Knee Systems	K112891	FDA 510(k)	Class II	Active
Apex Revision Knee System	K163332	FDA 510(k)	Class II	Active
Apex-Lnk Poly Acetabular Cup Liners	K073150	FDA 510(k)	Class II	Active
Apex Revision Knee System	K153437	FDA 510(k)	Class II	Active
Apex Arc Hip Stem	K090845	FDA 510(k)	Class II	Active
Tibial Baseplate Augment Model Kc-22118, Kc-22128, Kc-22138, Kc-22148, Kc-22158	K094017	FDA 510(k)	Class II	Active
Apex Arc Hip Stem	K111193	FDA 510(k)	Class II	Active
Apex Hip System Bipolar Head, Model H3-822xx And H3-828yy, Xx=od In [mm] (38-43), Yy=od In [mm](44-60)	K082468	FDA 510(k)	Class II	Active
Apex Knee Modular Tibia System	K131472	FDA 510(k)	Class II	Active
Monoblock Press-Fit Hip Stem	K060072	FDA 510(k)	Class II	Active
Interface Acetabular System, Acetabular Insert +4 Offset	K101976	FDA 510(k)	Class II	Active
Apex Arc Hip Stem	K113242	FDA 510(k)	Class II	Active
Apex Ps Knee System - Ps-C Insert	K111184	FDA 510(k)	Class II	Active
Omni Arc Monoblock Hip Stem	K133381	FDA 510(k)	Class II	Active
OMNI ARC Anteverted Neck Hip Stem	K172467	FDA 510(k)	Class II	Active
Apex Ps Knee System	K102578	FDA 510(k)	Class II	Active
Apex Knee System	K060192	FDA 510(k)	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.