FDA-Device2013-03-27Class II
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
DePuy Orthopaedics, Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA Nationwide.
Affected count
4000; 2600 in USA
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0971-2013Don't want to check this manually?
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