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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 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14 Slotted Femoral Head Provisional +3.5X28 00780302804 MIS 12/14 Slotted Femoral Head Provisional +7X28 00780302805 MIS 12/14 Slotted Femoral Head Provisional +10.5X28 00780302814 MIS 12/14 Slotted Femoral Head Provisional +7X28 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-2481-2012
Classification Class II
Code Info All lots including lot 78939000 (1/7/2002) to present
Product Distributed Qty 231,641 all lots, all sizes
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.
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