Recall Z-2517-2018— IMPLANTCAST GMBH

Name: FDA recall Z-2517-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-28

Class II · Terminated

Class II FDA medical device recall by IMPLANTCAST GMBH, initiated 2017-12-28, terminated 2020-09-01. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 mm REF number 02424652. Reason: Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted..

Recalling firm: IMPLANTCAST GMBH
Classification: Class II
Status: Terminated
Initiated: 2017-12-28
Terminated: 2020-09-01
Firm location: Buxtehude, N/A, Germany

Product description

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 mm REF number 02424652

Reason for recall

Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.

Data sourced from openFDA. This site is unofficial and independent of the FDA.