Class 2 Device Recall Depuy Mitek Lupine Loop Plus Anchor w/Orthocord

• Date Initiated by Firm: January 27, 2012
• Date Posted: March 06, 2012
• Recall Status: Terminated on August 05, 2015
• Recall Number: Z-1165-2012
• Recall Event ID: 61088
• 510(K)Number: K040827
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Code Information: Lot Numbers: 3254781 3259472 3259473 3263565 3265787 3273870 3274773 3275873 3276291 3278853 3280529 3285982 3286251 3291282 3292557 3294717 3300535 3303070 3303075 3303604 3307875 3309446 3313532 3314878 3315281 3318271 3319392 3320464 3324809 3328905 3331650 3332255 3339389 3340066 3356491 3357497 3361638 3368804 3372525 3374540 3375492 3378618 3380652 3382627 3385834 3386389 3389506 3392332 3393563 3394954 3401170 3401301 3403712 3404939 3406628 3410341 3412859 3413014 3414534 3414903 3417105 3418953 3424006 3424941 3430964 3431594 3432457 3432798 3437342 3441412 3447179 3449011 3449384 3451257 3453525 3454445 3458884 3472241 3473286 3474051 3487118 3488781 3489687 3491266 3492330 3498043 3508003 3509574 3513371 3514879 3516051 3519400 3522745 3524885 3529297 3532089 3533829 3539766 3545357 3545358 3549296 3551172 3551298 3557174 3557804 3558973 3562014 3565747 3570375
• 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: 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: 32408 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