Cirencester, N/A, United Kingdom
Corin Ltd recalls
8 recalls recorded since 2018, most recently on 13 October 2023. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)3
Terminated or completed5
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 October 2023
- Reason
- 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.
- Distribution
- US: MI, TX, IL
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0214-2024, Z-0213-2024
- Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Ongoing Class II Medical devices
- Recall started
- 8 November 2022
- Reason
- The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
- Distribution
- US Nationwide distribution in the states of FL, GA, MA, MI, Ok, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0727-2023, Z-0726-2023
- Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
- Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
Terminated Class II Medical devices
- Recall started
- 31 October 2022
- Terminated
- 12 January 2024
- Reason
- The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
- Distribution
- Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0273-2023
- Unity Total Knee System. Used for knee prosthesis in total knee replacement
Ongoing Class II Medical devices
- Recall started
- 22 July 2022
- Reason
- One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
- Distribution
- US Nationwide distribution in the states of OK, TX, FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1509-2022
- Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Terminated Class II Medical devices
- Recall started
- 12 July 2022
- Terminated
- 4 May 2026
- Reason
- Some of the devices did not pass fatigue testing.
- Distribution
- Distribution was made to NJ. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1667-2022
- TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Terminated Class II Medical devices
- Recall started
- 28 July 2021
- Terminated
- 12 June 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2611-2021, Z-2607-2021, Z-2609-2021, Z-2603-2021, Z-2612-2021, Z-2610-2021, Z-2605-2021, Z-2606-2021, Z-2608-2021, Z-2604-2021
- Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are c
- Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
- Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
- Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
- Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
- Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
- Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
- Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both a
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 6 May 2021
- Terminated
- 5 July 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1850-2021, Z-1851-2021
- Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
- Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
Terminated Class II Medical devices
- Recall started
- 25 January 2021
- Terminated
- 23 November 2022
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1290-2021, Z-1291-2021
- Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a mod
- Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modul
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.