openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 2 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 3 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 4 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 5 of 10
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 6 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 7 of 10
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 devices.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 8 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 9 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
device · product 10 of 10
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 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.
Code information
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.
Distribution pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
