||March 19, 2013
||Terminated on January 06, 2014
|Recall Event ID
Orthopedic manual surgical instrument -
||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
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.
||Product Code 96-6120
Label code / Etch code
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
|For Additional Information Contact
|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.
||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 firstname.lastname@example.org 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.
|Quantity in Commerce
||4000; 2600 in USA
||Worldwide Distribution - USA Nationwide.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.