Recall Z-2473-2012— 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: 00789502202 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: 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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