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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek LUPINE BR W/ORTHCORD

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  Class 2 Device Recall Depuy Mitek LUPINE BR W/ORTHCORD 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-1168-2012
Recall Event ID 61088
510(K)Number K040827  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Depuy Mitek LUPINE BR W/ORTHCORD
Catalog Number: 210711

The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code Information Lot Numbers: 3255035 3256894 3256896 3259849 3263567 3263803 3264300 3265999 3271669 3273869 3274015 3274934 3276542 3276834 3280531 3280845 3285984 3290088 3290939 3291738 3294017 3295566 3300220 3300536 3301731 3302338 3303603 3307032 3307876 3311516 3315589 3316893 3317373 3318272 3320159 3320807 3324464 3324685 3325368 3326719 3329111 3331020 3332251 3333687 3336171 3341986 3342900 3343806 3346327 3351894 3354114 3356160 3357666 3365694 3367538 3369757 3372529 3373951 3373988 3374924 3376168 3377021 3378619 3380103 3384937 3385002 3385431 3385913 3387386 3388427 3389562 3391245 3393643 3396506 3399781 3400687 3400790 3401642 3401792 3401866 3402163 3402340 3404933 3405150 3405246 3406969 3408705 3408707 3410342 3410343 3411973 3416514 3418589 3419026 3419374 3419380 3420418 3421698 3424017 3425290 3430313 3430555 3431590 3432062 3432316 3433687 3434680 3435516 3437353 3437671 3437946 3439327 3441414 3443288 3449390 3451255 3451458 3453524 3454158 3454449 3456434 3460903 3469156 3469508 3469949 3471145 3472099 3477995 3479092 3483728 3484279 3487120 3489728 3491812 3492973 3493152 3494966 3494967 3497118 3498139 3499243 3499718 3505907 3507061 3507364 3507367 3507586 3507697 3508064 3510566 3511829 3511925 3512550 3514916 3515699 3516820 3519399 3522428 3525171 3525173 3526422 3527741 3529524 3530371 3533721 3537832 3538872 3540918 3543023 3544837 3545355 3549273 3549621 3551002 3551375 3551905 3554779 3556768 3557171 3557797 3557805 3558970 3558976 3562011 3562221 3562225 3565745 3566059 3566065 3571651 
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 56468 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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