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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek Lupine Loop DS w/Orthocord

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  Class 2 Device Recall Depuy Mitek Lupine Loop DS w/Orthocord see related information
Date Initiated by Firm January 27, 2012
Date Posted March 06, 2012
Recall Status1 Terminated 3 on August 05, 2015
Recall Number Z-1171-2012
Recall Event ID 61088
510(K)Number K040827  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Depuy Mitek Lupine Loop DS w/Orthocord
Catalog Number: 222981

The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code Information Lot Numbers: 3262755 3262756 3270106 3291257 3307440 3323863 3335678 3343572 3354334 3363896 3372273 3375075 3380458 3394953 3408382 3408383 3416204 3423417 3425970 3431092 3432783 3441035 3447934 3455145 3459761 3464330 3492974 3504852 3508403 3508489 3525498 3528634 3534545 3540175 3541390 3550945 3554352 3556295 3557173 3558967 3562227 3566060 3568042 3568050 
Recalling Firm/
DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact Same
Manufacturer Reason
for Recall
Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
FDA Determined
Cause 2
Process control
Action DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.
Quantity in Commerce 12774
Distribution Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa
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