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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72113

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 08, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0111-2016
Recall number
Z-0111-2016
Initiated
September 08, 2015
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
7488

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

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.

Code information

SP2 IM Rod 400mm Instruments (96-6120) manufactured with 455 stainless steel (SS) or 17-4 SS; CATALOG NO. : 96-6120; GTIN 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; EJ7AP4; DK3FE4; EJ7A34; ES2G64; ES2HA4; FH8JX4; ES2HY4; EX5L44; C3JHN4; EX5MS4; C3JHS4; E2SD44; C3JHF4; C4GA54; C4GBT4; C4GCC4; C52F14; C52F74; C52GL4; C52GV4; C67N14; C98BF4; TBACC; TBACZ; FJ4E74; TBCOJ; & Manufactured with 17-4 Stainless Steel- Etched Lot #s- H0797; H0100; H0199; H0200; H0298; H0301; H0396; H0399; H0401; H0495; H0499; H0530; H0596; H0598; H0600; H0601; H0696; H0699; H0796; H0797; H0800; H0899; H0900; H0997; H0998; H1095; H1097; H1195; H1198; H1297; H1298; H1299

Distribution pattern

Worldwide Distribution - US including AL; AZ; CA; CO; CT; DC; FL; GA; HI; IA; IL; IN; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; NE; NH; NJ; NV; NY; OH; OR; PA; RI; SC; TN; TX; UT; VA; VT; WA; WI; and WV and Internationally to ARGENTINA; AUSTRALIA; AUSTRIA; BELGIUM; BRAZIL; CANADA; CHILE; COLOMBIA; CZECH REPUBLIC; EGYPT; FRANCE; GERMANY; GREECE; INDIA; ISRAEL; ITALY; KOREA; Mexico; NEW ZEALAND; NORWAY; P R CHINA; PANAMA; PERU; POLAND; RUSSIA; SINGAPORE; SLOVENIA; SOUTH AFRICA; SWITZERLAND; UAE; UK; URUGUAY; VENEZUELA; and VIETNAM.