Recall Z-2605-2021 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Corin Ltd
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.
| Date | Jul 28, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Storage |
| 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. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123705 | TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS Corin USA, Feb 12, 2013 |