Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0589-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ITST THREADED GUIDE PIN

Product Classification:

Class II

Date Initiated: November 5, 2013

Date Posted: January 8, 2014

Recall Number: Z-0589-2014

Event ID: 66499

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

Status: Terminated

Product Quantity: 42, 065 units total

Code Information:

Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24, 2023

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated