Recall Z-1133-2015— Zimmer Gmbh

Name: FDA recall Z-1133-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Gmbh, initiated 2014-12-17, terminated 2015-09-23. It names one FDA 510(k) clearance: K033634. Product: Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.. Reason: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision..

Recalling firm: Zimmer Gmbh
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Terminated: 2015-09-23
Firm location: Winterthur, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K033634 — EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODEDCenterpulse Orthopedics, Inc.·cleared 2004-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Metasul Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

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