Recall Z-1948-2015— Zimmer, Inc.

Name: FDA recall Z-1948-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-02

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-10-02, terminated 2015-07-01. It names one FDA 510(k) clearance: K973412. Product: Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.. Reason: Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-02
Terminated: 2015-07-01
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K973412 — NATURAL-KNEE II CONSTRAINED KNEE SYSTEMSulzer Orthopedics, Inc.·cleared 1997-12-08

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

Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.

Reason for recall

Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.

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