Z-1165-2012

Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated...

Name: Z-1165-2012 Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2012-01-27
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2012-01-27 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation on 2012-01-27. The reason FDA records is "Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1165-2012
Status: Terminated
Initiated: 2012-01-27
Posted: 2012-03-06
Terminated: 2015-08-05
Recalling firm: DePuy Mitek, Inc.
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.
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: 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

Product code MAI

K040827Class IIPanalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company / cleared 2004-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)