Corin recalls

Corin appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2023-11-08.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Unity Total Knee System, Model Number 112.001.34
  FDA Device · Class II · 2023-11-08 · Corin
  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.
• Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
  FDA Device · Class II · 2023-11-08 · Corin
  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.
• Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
  FDA Device · Class II · 2022-12-28 · Corin
  Reason: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
• Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
  FDA Device · Class II · 2022-12-28 · Corin
  Reason: The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
• Unity Total Knee System
  FDA Device · Class II · 2022-11-30 · Corin
  Reason: The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
• TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800
  FDA Device · Class II · 2022-09-07 · Corin
  Reason: Some of the devices did not pass fatigue testing.
• Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
  FDA Device · Class II · 2022-08-17 · Corin
  Reason: One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
• 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
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee…
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head,…
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular S…
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size…
  FDA Device · Class II · 2021-10-06 · Corin
  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.
• Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002
  FDA Device · Class II · 2021-06-23 · Corin
  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.
• Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007
  FDA Device · Class II · 2021-06-23 · Corin
  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.
• Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Cerami…
  FDA Device · Class II · 2021-03-31 · Corin
  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-ve…
• Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceram…
  FDA Device · Class II · 2021-03-31 · Corin
  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-ve…