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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek Lupine Loop OC violet

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  Class 2 Device Recall Depuy Mitek Lupine Loop OC violet 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-1170-2012
Recall Event ID 61088
510(K)Number K040827  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Depuy Mitek- Lupine Loop O-C violet
Catalog Number: 222980
The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code Information Lot Numbers: 3260754 3260755 3267471 3267856 3279142 3283274 3294346 3308178 3316616 3324437 3335675 3335680 3335912 3345809 3348331 3356158 3356931 3363895 3367218 3372238 3376111 3379721 3392180 3396183 3399549 3402848 3407843 3407853 3411158 3411464 3413924 3414791 3415998 3425969 3430034 3432456 3432784 3438970 3442424 3446284 3447178 3456890 3464329 3466042 3469505 3471047 3477613 3482031 3485711 3496678 3504580 3508148 3508476 3508983 3529766 3534930 3539137 3547740 3551900 3554353 3557169 3557795 3558963 3560269 3560274 3562017 3566058 3568048 3571646 
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact Same
508-880-8100
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 20476 units
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
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