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U.S. Department of Health and Human Services

Class 2 Device Recall Specialist 2

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  Class 2 Device Recall Specialist 2 see related information
Date Initiated by Firm February 05, 2013
Date Posting Updated March 19, 2013
Recall Status1 Terminated 3 on January 06, 2014
Recall Number Z-0971-2013
Recall Event ID 63973
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product 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.
Code Information Product Code 96-6120, Label code / Etch code, C3JHN4 H0808, C3JHS4 H0908, C3JHF4 H1008, C4GA54 , C4GCC4 , C4GBT4 , C52F74 H1108, C52GV4 H1208, C52GL4 , C67N14 , C98CS4 H0109, C98BF4 , DE5P34 H0309, DE5RP4 , DF4H44 , DG9LK4 H0409, DG9L64 , DJ5E34 , DK3E34 H0509, DK3FE4 , EB5FV4 H0210, D95AN4 , EB5GH4 H0310, EC9JY4 , EF4DJ4 , EJ7AP4 H0410, ES2G64 H0510, EJ7A34 , ES2HA4 H0610, ES2HY4 H0710, EX5L44 , EX5MS4 H0810, E2SD44 H0910, FA4G94 H0211, FD8MP4 H0311, FH8JA4 , FH8JX4 H0611, TBACC TBACC, TBACZ TBACZ, FJ4E74 TBAGG.
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy Tinsley
Manufacturer 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.
FDA Determined
Cause 2
Device Design
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 kseppa@its.jnj.com 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
Distribution Worldwide Distribution - USA Nationwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.