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U.S. Department of Health and Human Services

Class 2 Device Recall Lupine Loop Plus w/ Orthocord DS

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  Class 2 Device Recall Lupine Loop Plus w/ Orthocord DS see related information
Date Initiated by Firm October 31, 2011
Date Posted November 30, 2011
Recall Status1 Terminated 3 on August 05, 2015
Recall Number Z-0316-2012
Recall Event ID 60287
510(K)Number K062170  K070925  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product DePuy Mitek Lupine Loop Plus w/ Orthocord DS
Catalog #210709

The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
Code Information Lot number 3549732; Product code: 210709
Recalling Firm/
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact Same
Manufacturer Reason
for Recall
Incorrect suture configuration
FDA Determined
Cause 2
Employee error
Action The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: mitekcomplaints@its.jnj.com (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.
Quantity in Commerce 291 units
Distribution Worldwide distribution: USA (nationwide) and countries of: Austria, Australia, Brazil, Canada, Estonia,Switzerland, China, Czechoslovakia, Denmark, Spain, Finland, France, Great Britain Israel, India, Japan, Korea, Mexico, Martinique, Norway, Portugal, Sweden, Singapore, Solvonia, and Slovakia.
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.
510(K) Database 510(K)s with Product Code = MAI and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY