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.
FDA Recall Z-2604-2021 · Posted None
Recalling FirmCorin Ltd
Recall StatusTerminated
Product CodeMEH
Date Initiated2021-07-28
Date Terminated2024-06-12
Product Quantity6 units
Reason for 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.
Firm Action
On 7/28&29/2021, the firm sent emails entitled "IMPORTANT-containment request FA COUK 2021 013" which notified the consignee they have been identified as receiving one or more of the medical devices listed in the attached Excel file due to them potentially having physical and/or water damage. They were to quarantine the parts until further instructions were issued. On 9/7/2021, Corin USA issued recall letters dated 9/3/2021 via email on 9/7/2021 requesting the devices be quarantined and returned.
Root Cause
Storage
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.