Recall Z-0920-2018 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Signature Orthopedics Pty Limited
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are
| Date | Feb 2, 2018 |
| Status | Terminated |
| Reason | This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved. |
| Root cause | Labeling mix-ups |
| Action | Signature Orthopaedics notified customer(s) of the recall by sending an Urgent Medical Device Recall Letter dated February 2, 2018 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Acknowledgement Form and firm's Effectiveness Check Questionnaire. |
| Quantity | 10 |
| Distribution | Worldwide Distribution - U.S. Nationwide and the country of Australia. |
| 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 |