Recall Z-1134-2015— Zimmer Gmbh

Name: FDA recall Z-1134-2015
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: K071535. Product: Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.. 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

K071535 — BIOLOX DELTA CERAMIC FEMORAL HEADZimmer, Inc.·cleared 2007-11-19

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

Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral Head is used in conjunction with compatible acetabular and femoral stem components in total hip arthroplasty. A variety of sizes and neck lengths are available for various patient anatomies and adjustment of the tension of the ligaments and reconstruction of the center of the natural head of the femur.

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.