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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS

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 Class 2 Device Recall Depuy Mitek LupineLoopPlus Anchor w/Orthocord DSsee related information
Date Initiated by FirmJanuary 27, 2012
Date PostedMarch 06, 2012
Recall Status1 Terminated 3 on August 05, 2015
Recall NumberZ-1166-2012
Recall Event ID 61088
510(K)NumberK040827 
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
ProductDepuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code Information Lot Numbers: 3254891 3255034 3263566 3265788 3271667 3274014 3275848 3278854 3280530 3285983 3291737 3292679 3301541 3303082 3307441 3310874 3314468 3316690 3317375 3318420 3320462 3324467 3325365 3329112 3335908 3342267 3342269 3345993 3349577 3352888 3365987 3369756 3374558 3377520 3381940 3386941 3387259 3395185 3396187 3396396 3401431 3401638 3403914 3406629 3406968 3413445 3414931 3415168 3418983 3420848 3431721 3433230 3434054 3435821 3438965 3442446 3449646 3452857 3455281 3470842 3476093 3477803 3484272 3487119 3489688 3494965 3496820 3504366 3504853 3510568 3515580 3519667 3529351 3532090 3538865 3544392 3549732 3551001 3554778 3557175 3558965 3560275 3562226 3570372 
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information ContactSame
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
ActionDePuy 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 Commerce24146 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MAI
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