Recall Z-0586-2014— Zimmer, Inc.

Name: FDA recall Z-0586-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-05

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-11-05, terminated 2015-05-05. It names one FDA 510(k) clearance: K130595. Product: TIBIO FEM/FEM NAIL.. Reason: Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-11-05
Terminated: 2015-05-05
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K130595 — ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAILZimmer, Inc.·cleared 2013-09-17

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

TIBIO FEM/FEM NAIL.

Reason for recall

Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure

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