Recall Z-2033-2014— Zimmer, Inc.

Name: FDA recall Z-2033-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-23

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-05-23, terminated 2015-03-06. It names one FDA 510(k) clearance: K032726. Product: Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.. Reason: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Terminated: 2015-03-06
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K032726 — ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIESZimmer, Inc.·cleared 2003-10-22

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

Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.

Reason for recall

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

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