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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy Sigma LCS

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  Class 2 Device Recall DePuy Sigma LCS see related information
Date Initiated by Firm January 08, 2016
Date Posted February 09, 2016
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-0787-2016
Recall Event ID 73076
Product Classification Punch, surgical - Product Code LRY
Product SIGMA HP MBT Non-Keel Punch Knee Instrument.
Designed to be used as an option in stabilizing the tibial trial during trial reduction.
Code Information Cat. No. GTIN Lot Description  950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5  950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3  950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7  950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3  950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7  950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact Kimberly C. Earle
Manufacturer Reason
for Recall
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
FDA Determined
Cause 2
Component design/selection
Action On 1/8/2016, URGENT INFORMATION  RECALL NOTICE for Specific Lots of SIGMA¿ High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.  5 p.m. EDT). For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT).
Quantity in Commerce 351
Distribution Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.
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.