Chrysalis Intelligence · Sponsors · Corin, Ltd.

Corin, Ltd.

Raynham, MA, US · 4 510(k) clearances · 21 recalls

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Total clearances
4
2020-06-27 → 2026-09-17
Last 12 months
2
Product codes
4
Most recent
2026-09-17
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Class II Orthopedic 1 2026-09-17
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class II Orthopedic 1 2026-08-10
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class II Orthopedic 1 2021-07-28
OLO Orthopedic Stereotaxic Instrument Class II Neurology 1 2020-06-27
Safety

Recalls (21)

Class I (serious)
0
Risk of injury / death
Total recalls
21
Currently ongoing
5
Most recent
2023-10-13
DateSeverityStatusRecall # ProductCodeReason
2023-10-13 Class II Ongoing Z-0214-2024 Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty — 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.
2023-10-13 Class II Ongoing Z-0213-2024 Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty — 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.
2022-11-08 Class II Ongoing Z-0727-2023 Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 — The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
2022-11-08 Class II Ongoing Z-0726-2023 Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215 — The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
2022-10-31 Class II Terminated 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 the packaging.
2022-07-22 Class II Ongoing Z-1509-2022 Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103 — One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
2022-07-12 Class II Terminated Z-1667-2022 TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip i… — Some of the devices did not pass fatigue testing.
2021-07-28 Class II Terminated Z-2612-2021 Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity … — 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 devi…
2021-07-28 Class II Terminated Z-2611-2021 Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity K… — 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 devi…
2021-07-28 Class II Terminated Z-2610-2021 Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of t… — 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 devi…
2021-07-28 Class II Terminated Z-2609-2021 Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile. — 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 devi…
2021-07-28 Class II Terminated Z-2608-2021 Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 … — 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 devi…
2021-07-28 Class II Terminated Z-2607-2021 Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Ac… — 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 devi…
2021-07-28 Class II Terminated Z-2606-2021 Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner… — 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 devi…
2021-07-28 Class II Terminated Z-2605-2021 Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the T… — 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 devi…
2021-07-28 Class II Terminated Z-2604-2021 Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, d… — 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 devi…
2021-07-28 Class II Terminated Z-2603-2021 Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile. — 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 devi…
2021-05-06 Class II Terminated Z-1851-2021 Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component. — 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.
2021-05-06 Class II Terminated Z-1850-2021 Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component. — 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.
2021-01-25 Class II Terminated Z-1291-2021 Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity … — 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 Bi…
2021-01-25 Class II Terminated Z-1290-2021 Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity… — 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 Bi…
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2026-09-17 K261275 Unity Total Knee System, Unity Knee Cementless CR Femur MBH Class II Orthopedic
2026-08-10 K261576 Icona Hip Stem MEH Class II Orthopedic
2021-07-28 K201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads LZO Class II Orthopedic
2020-06-27 K200888 OMNIBotics Knee System OLO Class II Neurology
Data source: openFDA · Generated 2026-09-29 10:43 · Last ingest 2026-09-29T14:43:06.673184 · Pipeline: Chrysalis Intelligence