Recall Z-0400-2013— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2010-10-10, terminated 2014-04-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.

Classification

Class II

Status

Terminated

Initiated

2010-10-10

Terminated

2014-04-30

Firm location

Warsaw, IN, United States

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