FDA (Devices) recall action 88589
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Corin Ltd is recalling Corin MetaFix Hip Stem, Size 1 devices due to potential physical and water damage to packaging that could compromise device sterility and cause contamination.
Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.
Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US states in July 2021.
Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.
Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.
Corin Ltd recalls two models of Unity Knee CS Insert implant components due to potential packaging damage that could compromise sterility or cause contamination. Affected devices were distributed in nine U.S. states in July 2021.
Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.
Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.
Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.
Corin Ltd is recalling specific Trinity Dual Mobility hip implant components due to packaging damage that may compromise sterility. The affected products were distributed to medical facilities in nine states.