Z-0400-2013 Class II Terminated
FDA device recall Z-0400-2013 was initiated by Zimmer, Inc. on Oct 10, 2010 and is designated Class II. Reason for recall: Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced… The recall status is terminated (terminated Apr 30, 2014). Affected quantity: 56,516 all lots, all sizes.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Oct 10, 2010
- Termination Date
- Apr 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56,516 all lots, all sizes
Product Description
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 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.
Reason for Recall
Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to 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. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.
Code Information
All lots distributed from lot 69998600 (2/20/1996) to present
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0400-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026