OMNIlife science, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000015882 FEI 3013682146
- Devices
- 3,456
- Registrations
- EUDAMEDFDA
- FDA recalls
- 47
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 3,456 devicesShowing 1-50 of 3,456
Company details
- EUDAMED SRN
- US-MF-000015882
- FDA FEI number
- 3013682146
- EUDAMED status
- Active
- EUDAMED registered name
- OMNIlife science, Inc.
- EUDAMED abbreviated name
- OMNI
- Registered address
- 480, Paramount Drive, 02767, Raynham, United States
- PRRC contact
- Christina Rovaldi
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 2
- 2019 5
- 2020 3
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 1 Oct 2021 Z-0237-2022 Class II 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.
2020
- 21 Dec 2020 Z-0920-2021 Class II 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
- 21 Dec 2020 Z-0921-2021 Class II 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
- 21 Dec 2020 Z-0922-2021 Class II 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
2019
- 11 Sep 2019 Z-0169-2020 Class II Terminated Stems missing porous coating on the device.
- 23 Jul 2019 Z-2479-2019 Class II Terminated Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- 23 Jul 2019 Z-2480-2019 Class II Terminated Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- 23 Jul 2019 Z-2481-2019 Class II Terminated Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- 12 Apr 2019 Z-1717-2019 Class II Terminated The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
2018
- 29 Nov 2018 Z-0837-2019 Class II Terminated There is a potential for the inner pin of the handle to become loose and fall out.
Show the 25 most recent of 47 recalls
2018
- 18 May 2018 Z-2540-2018 Class II Terminated The Internal packaging, the pouch and patient labels are improperly labeled.
2017
- 20 Nov 2017 Z-1117-2018 Class II 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.
2016
- 14 Oct 2016 Z-0610-2017 Class III Terminated Incorrect lot number on outer kit
2015
- 9 Jun 2015 Z-2454-2015 Class II 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.
- 9 Jun 2015 Z-2455-2015 Class II 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.
- 4 Jun 2015 Z-2445-2015 Class II Terminated The device may have improper screw hole placement due to inaccurate location of the index line.
- 3 Jun 2015 Z-2064-2015 Class II Terminated Product may breach the inner and outer sterile pouches during shipping or handling.
2014
- 9 May 2014 Z-2241-2014 Class II Terminated Staining on hip implant.
2012
- 9 Aug 2012 Z-2370-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Full distribution text
- 9 Aug 2012 Z-2371-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Full distribution text
- 9 Aug 2012 Z-2372-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Full distribution text
- 9 Aug 2012 Z-2373-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Full distribution text
- 9 Aug 2012 Z-2374-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Full distribution text
- 9 Aug 2012 Z-2375-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
Full distribution text
- 9 Aug 2012 Z-2370-2012 Class II Terminated The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
2009
- 10 Jul 2009 Z-1966-2009 Unclassified (pre-2012) Terminated The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head.
Frequently asked questions
How many devices does OMNIlife science, Inc. have in the registry?
The registry currently lists 3456 devices for OMNIlife science, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list OMNIlife science, Inc.'s devices?
Among its 50 most recently registered devices, OMNIlife science, Inc. has devices listed in EUDAMED (40 devices) and FDA GUDID (33 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do OMNIlife science, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for OMNIlife science, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for OMNIlife science, Inc.?
FDA recall records list 47 recalls initiated by OMNIlife science, Inc., the most recent initiated on 1 Oct 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from OMNIlife science, Inc. in the registry?
The most recently registered devices listed for OMNIlife science, Inc. include APEX Revision Knee System – Revision Femur Size 1-3+ Trials Pan Insert, AK3 TIBIAL TRAY TRIAL, sz 6L, AK3 TIBIAL TRAY TRIAL, sz 4L and AK3 TIBIAL TRAY TRIAL, sz 3R.