Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Pro...
FDA Recall #Z-0389-2013 — Class II — October 10, 2010
Product Description
Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper 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
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
128,946 all lots, all sizes
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated