Recall Z-0389-2013— 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: 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: 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.