Corin Ltd
Country not established FDA
- Devices
- 4,230
- Registrations
- FDA
- FDA recalls
- 215 ongoing
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Corin Ltd makes
Corin Ltd manufactures reusable orthopaedic instruments for prosthesis implantation positioning, including tibial inserts, acetabular shells, and acetabulum trial prostheses. Their portfolio also includes modular hip femur prostheses, acetabular reamers, knee tibia trial prostheses, and non-constrained polyethylene acetabular liners, as well as modular knee systems with fixed meniscus components.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.
Catalogue
Search and filter all 4,230 devicesShowing 1-50 of 4,230
Company details
- DUNS number
- 295437313
- [email protected]
- Phone
- +330456608978
FDA recalls
FDA recall records list 21 recalls initiated by CORIN LTD, the earliest on 2021-01-25 and the most recent on 2023-10-13. By recorded status: 5 ongoing and 16 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 14
- 2022 5
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 13 Oct 2023 Z-0213-2024 Class II Ongoing Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
- 13 Oct 2023 Z-0214-2024 Class II Ongoing Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
2022
- 8 Nov 2022 Z-0726-2023 Class II Ongoing The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- 8 Nov 2022 Z-0727-2023 Class II Ongoing The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- 31 Oct 2022 Z-0273-2023 Class II Terminated The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
- 22 Jul 2022 Z-1509-2022 Class II Ongoing One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
- 12 Jul 2022 Z-1667-2022 Class II Terminated Some of the devices did not pass fatigue testing.
2021
- 28 Jul 2021 Z-2603-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2604-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2605-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Show all 21 recalls
2021
- 28 Jul 2021 Z-2606-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2607-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2608-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2609-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2610-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2611-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 28 Jul 2021 Z-2612-2021 Class II Terminated The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
- 6 May 2021 Z-1850-2021 Class II Terminated Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
- 6 May 2021 Z-1851-2021 Class II Terminated Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
- 25 Jan 2021 Z-1290-2021 Class II Terminated The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
- 25 Jan 2021 Z-1291-2021 Class II Terminated The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.
FDA establishments
- Corin Limited CIRENCESTER Gloucestershire · GB FEI 3002806725
Frequently asked questions
How many devices does CORIN LTD have in the registry?
The registry currently lists 4230 devices for CORIN LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list CORIN LTD's devices?
Among its 50 most recently registered devices, CORIN LTD has devices listed in FDA GUDID (50 devices).
What risk classes do CORIN LTD's devices fall under?
Among its 50 most recently registered devices, the classes recorded for CORIN LTD's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for CORIN LTD?
FDA recall records list 21 recalls initiated by CORIN LTD, the most recent initiated on 13 Oct 2023. 5 of them are recorded as ongoing. 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 CORIN LTD in the registry?
The most recently registered devices listed for CORIN LTD include Unity Total Knee System 1127309, Unity Total Knee System 1126909, Unity Total Knee System 1127209 and Unity Total Knee System 1127109.
Which FDA establishments are linked to CORIN LTD?
1 FDA establishment is linked to CORIN LTD in the registry; they are listed on the company page.