—#139894

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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.

Timeline

Recall initiated: 2015-09-08
Posted by FDA: 2015-10-07
Terminated: 2018-07-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139894. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.