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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty
Recall Number Z-0394-2013
Classification Class II
Code Info All lots distributed from lot 69998600 (2/20/1996) to present
Product Distributed Qty 128,946 all lots, all sizes
Reason For Recall Zimmer is in the process of enhancing the surgical technique instructions for the Versys and Slotted Provisional Femoral Heads. These enhancements inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. The observed rate of occurrence for this type of event is approximately 0.001% or 1 in every 100,000 surgeries performed.

Event Detail

Event Id 63066
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-10-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.