FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: 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
- Recall number
- Z-0111-2016
- Recalling firm
- DePuy Orthopaedics, Inc.
- 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
- Status
- Terminated
- Initiated
- 2015-09-08
- Posted
- 2015-10-07
- Terminated
- 2018-07-03
- 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.
- Root cause
- Device Design
- Action
- DePuy Synthes sent an Urgent Information Recall Notice to all affected customers. Instruments are not lot traceable in the system, so the company sent notices by e-mail on September 8, 2015, and US Distributors will hand deliver notices to all Medical Facilities that may have purchased the affected instrument. The US Distributor or US Sales Consultant will deliver the Medical Professional Notice and Reconciliation Form to the affected Medical Facilities. If assistance is needed, Sales Consultants will assist customers with inspection of all instruments, return of affected lots, receiving credit and returning the completed Medical Facility Reconciliation Forms to DePuy Orthopaedics, Inc. The affected instruments will be returned to the quarantine warehouse located at 700 Orthopaedic Drive, Warsaw, IN 46582. For questions regarding this recall call 574-371-4917. For questions regarding this recall call 574-267-8143.
- Quantity
- 7488
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28