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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description 12/14 Neck Taper 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 MIS Femoral 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-2478-2012
Classification Class II
Code Info All lots distributed from lot 69998600 (2/20/1996) to present
Product Distributed Qty 231,641
Reason For Recall Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Some reports of intraoperative dislodging of the provisional head have also been received. 13 of the complaints allege that the provisional head was left in-vivo after separating from mating components during surgery. An April 2001 letter was sent to all distributors and operation managers in the US explaining the events. A June 2011 letter was sent to distributors in Canada.

Event Detail

Event Id 62110
Product Type Devices
Status Ongoing
Recalling Firm Zimmer, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-04-01
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.