Recall Z-1291-2021 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Corin Ltd
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo mo
| Date | Jan 25, 2021 |
| Status | Terminated |
| Reason | The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa. |
| Root cause | Labeling mix-ups |
| Action | The firm contacted their consignee by email on 01/25/2021. The distributor was instructed to identify the affected product in its inventory and return it to Corin USA in order to contain the part. A recall letter will be sent and acknowledgement of receipt will be requested. |
| Quantity | 23 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Colombia, Poland, Germany, Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130343 | CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS Corin USA, May 28, 2013 |