Recall Z-2482-2012— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2011-04-01, terminated 2014-05-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS 12/14 Slotted Femoral Head Provisional +3.5X32 00780303204 MIS 12/14 Slotted Femoral Head Provisional +7X32 00780303205 MIS 12/14 Slotted Femoral Head Provisional +10.5X32 00780303214 MIS 12/14 Slotted Femoral Head Provisional +7X32 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: 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. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp.

Recalling firm

Zimmer, Inc.

Classification

Class II

Status

Terminated

Initiated

2011-04-01

Terminated

2014-05-16

Firm location

Warsaw, IN, United States

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