Recall Z-2050-2021 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
IMPLANTCAST GMBH
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 0
| Date | Jul 9, 2021 (initiated May 10, 2021) |
| Status | Terminated |
| Reason | A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor. |
| Root cause | Device Design |
| Action | On May 10, 2021 Urgent Safety Information notices were emailed to customers who were asked to take the following action: 1. Read this safety information carefully and make sure all relevant departments and officeholders are informed about its content. 2. Keep this safety information. 3. Fill in and return the reply form. Customers with additional questions were encouraged to contact Wendy Ryan-Kettler at WRyan@implantcast-na.com On 17 May, 2017, a follow-up Medical Device Correction notice was emailed to customers who were asked to take the following additional actions: 4. Destroy the affe |
| Quantity | 41 units (U.S.) |
| Distribution | U.S. Nationwide distribution in the states of FL and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163577 | Ecofit® Hip System Implantcast GmbH, Sep 25, 2017 |