Recall Z-0111-2016— DePuy Orthopaedics, Inc.

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2015-09-08, terminated 2018-07-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C.¿ SIGMA¿ Specialist¿ 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C.¿ SIGMA¿ Specialist ¿ 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. ¿ SIGMA¿ High Performance (HP) Primary Knee Instruments. Reason: DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients..

Recalling firm

DePuy Orthopaedics, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-09-08

Terminated

2018-07-03

Firm location

Warsaw, IN, United States

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