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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek LUPINE BR DS W/ORTHCRD

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  Class 2 Device Recall Depuy Mitek LUPINE BR DS W/ORTHCRD 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-1169-2012
Recall Event ID 61088
510(K)Number K040827  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Depuy Mitek LUPINE BR DS W/ORTHCRD
Catalog Number: 210712

The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code Information Lot Numbers: 3253246 3253247 3259850 3259851 3264301 3265378 3265586 3266000 3266325 3267855 3274774 3275874 3276289 3277205 3277262 3278352 3278353 3280846 3280847 3284476 3290078 3290087 3290378 3290379 3291258 3292552 3294319 3294348 3301539 3301542 3303587 3303695 3309447 3313661 3313974 3316614 3317015 3317376 3318617 3320165 3320463 3324471 3324688 3325377 3328084 3329341 3330171 3333686 3335681 3336201 3342265 3342751 3343813 3345940 3346328 3352891 3353761 3354434 3356927 3361636 3363320 3365436 3366094 3367357 3368805 3370084 3372361 3372656 3374385 3375082 3375502 3376419 3377033 3378992 3379722 3381145 3382230 3385518 3386705 3391246 3391247 3391248 3391639 3393649 3395552 3398044 3398611 3399046 3399552 3400404 3400794 3403170 3403628 3403629 3404444 3405149 3405395 3405398 3406630 3406970 3410794 3410983 3416798 3418131 3419667 3419668 3421833 3422643 3422886 3424271 3424319 3424652 3425061 3425293 3429453 3429454 3430365 3430625 3430965 3431093 3431591 3431732 3432063 3432458 3433965 3434794 3435841 3439398 3441063 3441757 3442814 3445429 3447916 3447933 3450118 3451256 3451258 3451461 3453746 3454940 3456090 3456319 3458062 3466043 3468453 3469502 3469510 3469615 3475015 3476161 3476649 3478156 3478613 3479322 3480844 3481910 3482379 3484501 3486777 3487121 3492081 3494968 3494969 3496085 3499610 3501541 3502367 3503815 3504360 3505148 3505190 3505193 3507062 3507365 3507368 3507677 3507698 3510567 3512031 3512584 3513048 3514234 3515249 3517059 3519398 3522427 3522744 3523510 3523827 3524326 3524616 3526367 3527750 3528960 3529616 3530392 3530718 3534110 3534801 3535970 3537098 3538646 3539347 3540616 3541389 3541814 3544672 3544838 3546678 3549749 3551376 3552577 3553100 3555032 3555674 3557172 3557798 3557801 3558966 3558974 3560272 3562010 3562012 3564051 3564055 3566062 3568043 3568046 3570365 3570368 3570370 3570376 3571652 
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.
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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