Recall Z-1694-2021 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Signature Orthopedics Pty Limited
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
| Date | Apr 20, 2021 |
| Status | Terminated |
| Reason | Product mislabeled, with the incorrect product inside the package. |
| Root cause | Labeling mix-ups |
| Action | On 04/20/21 the firm sent a letter to its consignee with the following instructions: examine your inventory and quarantine product subject to recall. In addition, if you have further distributed this product, please identify your customers and notify them at once by forwarding this letter. Please complete the Customer Acknowledgement Form. |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the state of NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR Signature Orthopaedics Pty, Ltd., Dec 28, 2012 |