Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with

FDA device recall Z-1981-2013 · posted 2013-08-17 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single 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 single packaging tray configuration, which

Action taken

Zimmer is removing the devices from the field including distributor and hospital inventories. A notification was issued to known users of the product on 07/16/2013.

Root cause

Packaging process control

Status

Terminated

Product code

JDG

Quantity affected

1,710 units are in distribution

Distribution

Worldwide Distribution-USA (nationwide) including the states of CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI, and the countries of Singapore, Canada,

Date initiated

2013-07-16

Date posted

2013-08-17

Date terminated

2015-04-30

Location

Warsaw, IN