Corin Unity Knee CS Insert Recall: Packaging Damage Risk
Corin recalls specific knee implant components due to packaging issues that may cause device damage or contamination. Affected units shipped between July 22-26, 2021. Contact Corin for details.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Corin is recalling two specific knee implant components because their packaging might cause damage to the devices, leading to loss of sterility or contamination. This affects patients who received these implants during the specified delivery dates. Read more at govinfonow.com/recall/62127-corin-unity-knee-cs-insert-recall-packaging-damage-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62127-corin-unity-knee-cs-insert-recall-packaging-damage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2611-2021
Cite this page
“Corin Unity Knee CS Insert Recall: Packaging Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62127-corin-unity-knee-cs-insert-recall-packaging-damage-risk. Based on FDA recall #Z-2611-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2611-2021%22&limit=1).
Why it’s dangerous
The packaging system could be damaged, causing physical or water damage to the devices. This might lead to loss of sterility or contamination during surgical procedures.
Who’s affected
Patients who received the Corin Unity Knee CS Insert components between July 22-26, 2021, are most at risk. The recall targets specific implant models and lot numbers delivered during that timeframe.
How to tell if you have this one
Check for the model numbers 1125182 (lot 477942) or 1125243 (lot 479310) on the packaging. These implants were delivered to patients between July 22-26, 2021.
- Brand
Corin- Category
Medical device
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2603-2021 | Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 467870 was delivered to the consignee on 7/23/2021 and 7/26/2021. | 5 |
| Z-2604-2021 | Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.035 - Lot number 481070 was delivered 7/23/2021 and 7/26/2021; and Model 321.050 - Lot number 478892 was delivered 7/23/2021. | 6 units |
| 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 Trinity Acetabular System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 441120 was delivered to the consignee 7/23/2021 and 7/26/2021. | 2 units |
| Z-2606-2021 | 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 are components of the Trinity Acetabular System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 322.04.640 - Lot number 479381 was delivered 7/22/2021 and 7/23/2021; Model 322.04.936 - Lot number 479878 was delivered 7/22/2021 and 7/26/2021. | 5 units |
| Z-2607-2021 | Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 483603 was delivered 7/23/2021. | 4 |
| Z-2608-2021 | 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, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.04.540 - Lot number 478880 delivered 7/26/2021; Model 325.04.042- Lot number 480567 delivered 7/26/2021. | 2 |
| Z-2609-2021 | Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 476399 was delivered 7/22/2021 and 7/23/2021. | 2 units |
| Z-2610-2021 | Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 472687 was delivered 7/23/2021. | 1 unit |
| Z-2611-2021 | 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 components of the Unity Total Knee System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 1125182 - Lot number 477942 was delivered 7/22/2021; model 1125243 - Lot number 479310 was delivered 7/23/2021. | 2 units |
| 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 Total Knee System.; The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 473755 was delivered 7/26/2021. | 1 unit |
What to do — step by step
Check Packaging Details
Look for model numbers 1125182 (lot 477942) or 1125243 (lot 479310) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
FDA distribution: “US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Illinois, Oklahoma, Pennsylvania, Texas, Utah, Wisconsin.
Recall timeline
FDA terminated this recall 2.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2611-2021 (July 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2611-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.