EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole co
FDA device recall Z-2050-2021 · posted 2021-07-09 · Terminated
Recall details
- Recalling firm
- IMPLANTCAST GMBH
- Reason for recall
- 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.
- Action taken
- 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 affected (previous) surgical technique and instruction for use (IFU) and replace them with the updated versions that accompanied this safety information.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 41 units (U.S.)
- Distribution
- U.S. Nationwide distribution in the states of FL and TX.
- Date initiated
- 2021-05-10
- Date posted
- 2021-07-09
- Date terminated
- 2022-11-18
- Location
- Buxtehude, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Ecofit® Hip System (K163577) | Implantcast GmbH | 2017-09-25 |