Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) Recalled by DePuy Orthopaedics, Inc. Due to DePuy Orthopaedics, Inc. is initiating a voluntary recall...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Orthopaedics, Inc. directly.
Affected Products
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
Quantity: 7488
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 41 states: AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, DC
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report