Corin recalls specific Trinity-i hip implants (REF 320.03.350) delivered 7/22-26/2021 due to packaging that may cause water damage, loss of sterility, or contamination.
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 is recalling certain Trinity-i hip implant components because their packaging might get damaged by water, leading to loss of sterility or contamination. This could affect patients during surgery if the implants aren't properly sterile.
The packaging system could allow water to enter the sterile implant components, causing damage. This might lead to loss of sterility or contamination during surgical procedures if the implants aren't properly protected.
Patients who received the specific Trinity-i hip implant components (REF 320.03.350) delivered between July 22-26, 2021, are likely affected. Surgeons and medical facilities using these components are at highest risk.
Check for the product code REF 320.03.350 on the packaging. The affected components were delivered to medical facilities between July 22-26, 2021, with lot number 441120.
Look for the product code REF 320.03.350 on the packaging and verify delivery dates between July 22-26, 2021.
The packaging system may allow water damage, leading to loss of sterility or contamination of the implant components.
No, the recall is for specific delivery dates and packaging issues, not for active use. The remedy is not stated in the record.
Check the packaging for REF 320.03.350 and delivery dates between July 22-26, 2021. The official notice does not specify a remedy.
We’ve drafted a message you can send Corin to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2021 — Corin Corin Hello, I own a Corin that is covered by recall Z-2605-2021 from Corin. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.