Corin Limited — FDA Facility Profile
Corin Limited is an FDA-registered facility (FEI 3002806725) located in CIRENCESTER Gloucestershire, GB. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Oct 27, 2022: No Action Indicated (NAI)
- Inspections on record
- 6 (1 OAI, 2 VAI, 3 NAI)
- Last OAI inspection
- Mar 5, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 14, 2015
- Recalls as the recalling firm
- 10, latest Oct 2, 2026
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 27, 2022 | No Action Indicated (NAI) | No citations listed |
| Sep 12, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design input - Lack of or inadequate procedures (21 CFR 820.30(c)) Design verification - output does not meet input requirement (21 CFR 820.30(f)) Documentation (21 CFR 820.75(a)) and 5 more |
| Aug 18, 2016 | No Action Indicated (NAI) | No citations listed |
| Mar 5, 2015 | Official Action Indicated (OAI) | Design verification - Lack of or inadequate procedures (21 CFR 820.30(f)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Documentation (21 CFR 820.80(e)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 3 more |
| Nov 3, 2011 | No Action Indicated (NAI) | No citations listed |
| Oct 30, 2008 | Voluntary Action Indicated (VAI) | Process changes - review, evaluation and revalidation (21 CFR 820.75(c)) Documentation (21 CFR 820.100(b)) Justification for not reporting (21 CFR 806.20(b)(4)) Individual Report of Malfunction (21 CFR 803.50(a)(2)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 2, 2026 | Class II | Z-0356-2027 | Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part… Potential malfunction of the Modular Handles where the locking mechanism may fail. Any mating instruments already engaged to the handle will… |
| May 23, 2025 | Class II | Z-2069-2025 | Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130… Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. |
| Oct 13, 2023 | Class II | Z-0213-2024 | Unity CR Femur Right, Size 6, Model Number 112.001.32
Primary and revision total knee… and 1 more product 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… |
| Nov 8, 2022 | Class II | Z-0726-2023 | Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 and 1 more product The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. |
| Oct 31, 2022 | Class II | Z-0273-2023 | Unity Total Knee System.
Used for knee prosthesis in total knee replacement The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of… |
| Jul 22, 2022 | Class II | Z-1509-2022 | Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS… One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630. |
| Jul 12, 2022 | Class II | Z-1667-2022 | TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use… Some of the devices did not pass fatigue testing. |
| Jul 28, 2021 | Class II | Z-2603-2021 | Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. and 9 more products The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or… |
| May 6, 2021 | Class II | Z-1850-2021 | Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis… and 1 more product 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. |
| Jan 25, 2021 | Class II | Z-1290-2021 | Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System… and 1 more product The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is… |
Facility details
- Company
- CORIN MEDICAL, LTD.
- Location
- CIRENCESTER Gloucestershire (GB)
- Source
- device