Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 Product Usage: The SP2 IM Rod is used in both primary and revision 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 in both the SP2 and HP instrument kits.
FDA Recall Z-0971-2013 · Posted 2013-03-19
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Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-02-05
Date Terminated2014-01-06
Product Quantity4000; 2600 in USA
Reason for Recall
Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
Firm Action
DePuy Orthopaedics sent an Urgent Medical Device Correction Notice letter dated February 5, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the FAX back form to FAX 574-371-4939 or email [email protected] Questions about device correction information call Post Market Surveillance, 574-372-7333, Sales force questions call Product Specialist, 574-372-7303 and Surgeon questions DePuy's Scientific Information Office at 1-888-554-2482.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution - USA Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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