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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 Posted March 19, 2013
Recall Status1 Terminated 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/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Mindy Tinsley
574-372-7136
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 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.
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