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.
- Recall Initiated
- July 28, 2021
- Terminated
- June 12, 2024
- Recall Number
- Z-2606-2021
- Quantity
- 5 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.
Distribution
US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Lot / Code Info
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.
Root Cause
Storage
Action Taken
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.