Buxtehude, N/A, Germany
IMPLANTCAST GMBH recalls
2 recalls recorded since 2018, most recently on 10 May 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 May 2021
- Terminated
- 18 November 2022
- 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.
- Distribution
- U.S. Nationwide distribution in the states of FL and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2050-2021
- 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 ceme
Terminated Class II Medical devices
- Recall started
- 28 December 2017
- Terminated
- 1 September 2020
- Reason
- Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
- Distribution
- Distribution in Europe and US states of Texas, Rhode Island and Georgia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2517-2018
- 2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 02424448 Size 46/52
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.