Reported Oct 14, 2015 · Terminated
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- 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
- Lot codes and dates
78 of 78 products
Products covered by this recall Model / number Barcodes Product as published — SP2 IM Rod 400mm Instruments (96-6120) manufactured with 455 stainless steel (SS) or 17-4 SS 96-6120— — 10603295246893GTIN NO.: 10603295246893 — Lots: Manufactured with 455 Stainless Steel, Labeled Lot #s-C98CS4 — DE5P34 — DE5RP4 — D95AN4 — EB5FV4 — FA4G94 — DE1FA4 — DF4H44 — DG9LK4 — EB5GH4 — EC9JY4 — EF4DJ4 — FD8MP4 — FH8JA4 — DG9L64 — DJ5E34 — DK3E34 - Amount recalled
- 7488
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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